IV Flush Syringes often have pre-filled saline that helps to flush out medical devices that deliver drugs to the bloodstream via a catheter or needle.
When used and manufactured correctly, IV flush syringes are vital to patients and healthcare providers. These medical devices minimize the risk of infection and enhance workflow efficiency in healthcare settings. They also reduce the risk and frequency of needlestick injuries.
However, IV flush syringes carry a high risk of infection. If there’s contamination, the pathogens enter the bloodstream directly, which makes the condition lethal.
In 2016, the CDC became aware of a Burkholderia cepacia (B. cepacia) outbreak affecting five states. The agency investigated 162 cases of B. cepacia infections linked to contaminated Nurse Assist IV Flush syringes.
B. cepacia bacterial infection affects people who already have a weak immune system. People with existing lung conditions, pneumonia, and cystic fibrosis have challenges recovering from the initial illness.
If you or a loved one developed a bacteremia blood infection or sepsis after using a contaminated Flush IV syringe, you might qualify for a lawsuit. Join the Many supports people like you with legal resources that take the hard work of building and fighting a case off your shoulders.
History of IV Flush Syringes
IV Flush Syringes are standard in various healthcare settings. Medical professionals often use these devices in various aspects of patient care, including:
- Pain management and anesthesia
- Hematology and oncology
- Home infusion therapy
- Emergency medicine
All medical devices should be effective and safe and comply with stringent quality measures.
However, some manufacturers fail to ensure their products are safe and contamination-free. They distribute defective devices that often cause severe injuries to unsuspecting patients.
In 2016, the CDC announced an investigation into contaminated syringes produced by Nurse Assist. This decision followed reports of B. cepacia bloodstream infection outbreaks caused by the needles.
Health officials identified the bacterial infection in 164 patients from 59 medical facilities across five states. The cases were in Maryland, Delaware, Pennsylvania, New Jersey, and New York.
Seven of the 164 patients lost their lives, but the CDC was unsure whether it was due to underlying conditions or the infection.
Most bloodstream infection cases were in New Jersey, where officials confirmed 59 cases. Health officials confirmed 58 cases in New York and 30 in Pennsylvania. Twelve cases were in Maryland, and the remaining 4 cases were in Delaware.
Luckily, the CDC discovered that Nurse Assist syringes were likely causing the infections. The investigators successfully controlled the outbreak, and the national recall of the contaminated needles prevented more infections.
Although it’s unclear how sterile IV flush syringes picked up the bacteria, the CDC shared some insights on how the contamination likely occurred.
According to Dr. Richard B. Brooks, a former CDC researcher, proper sterilization using gamma radiation was enough to kill the bacteria. The contamination likely occurred because the syringes did not undergo adequate sterilization.
The sterilization process also likely had issues that made it ineffective. Another possible explanation was that the saline inside the syringes came into contact with the bacteria after sterilization.
B. Braun’s Bacteria-contaminated Syringes
B. Braun Medical Inc. also came under scrutiny in 2016 after the federal government filed a lawsuit against the company. The case accused B. Braun of distributing contaminated pre-filled IV flush syringes in 2007.
In 2006, B. Braun contracted AM2PAT Inc. (previously Sierra Pre-Filled) to produce pre-filled saline syringes. B. Braun got the IV flush syringes from AM2PAT’s North Carolina facility and distributed them to healthcare facilities across the country.
During negotiations, B. Braun became aware of some manufacturing issues at the production facility. AM2PAT agreed to relocate the manufacturing plant and contract a different syringe sterilization company.
However, B. Braun resumed distribution of the syringes after the changes before their quality team had a chance to review the new sterilization process. They also did not visit the new facility for inspection.
B. Braun knew about the disputable manufacturing processes yet continued distributing the saline syringes. The contaminated IV flush syringes eventually ended up in health facilities nationwide.
Due to B. Braun’s negligence, the contaminated syringes got recalled within two months of starting distribution.
The first IV flush syringe recall occurred after discovering that the sterilization process had significant flaws. The process left some toxic impurities in the saline inside the syringes.
B. Braun continued selling the IV flush syringes, although AM2PAT had yet to review the sterilization procedures.
Shortly after, dozens of patients in different facilities in multiple states fell ill due to the bacteria-contaminated IV flush syringes. The patients reported experiencing symptoms such as:
Patients who had weak immune systems suffered more complications. The Serratia marcescens bacterial infection caused life-threatening injuries and severe health complications.
The contaminated syringes sold by B. Braun caused bacterial infections in over 100 patients and at least five fatalities.
B. Braun eventually terminated the contract with AM2PAT in 2008 as the nationwide recall of the pre-filled IV flush syringes continued. Although the recall helped to prevent further infections, hundreds of vulnerable patients already suffered life-changing injuries.
Such negligent manufacturers should take responsibility for their actions or inaction.
If you believe you have a valid IV flush syringe lawsuit, Join the Many offers to connect you with the best legal team to fight on your behalf.
All Names IV Flush Syringes Go by
IV flush syringes contain Sodium Chloride at a concentration of 0.9 %. The generic name for these syringes is Normal Saline Flush. Various corporations manufacture(d) IV flush syringes in the US, including:
- Nurse Assist Inc.
- Hospira Inc.
- Becton Dickinson (BD) & Company
- B. Braun Medical Inc.
- Covidien LLC
- Medline Industries Inc.
- Excelsior Medical Corp
Some popular brand name examples include:
- HepMed IV Pack
- BD PosiFlush SF
- BD PosiFlush
- LiquiLift Trace Kit
- IV Novice Pack
- 0.9% Sodium Chloride IV Flush
- IV Infusion CPI
- Monoject Sodium Chloride Flush Syringe
- Monoject Prefill Sodium Chloride
- Active Injection Kit LM-Dep-1
- Active Injection Kit LM-DEP
- Tip-Lok Diluent
Overview of Research Findings
B. cepacia complex is a family of about 24 closely related bacteria species. These bacteria have versatile metabolism that allows rapid adaptation and mutation.
B. cepacia is often resistant to antiseptics and antibiotics. The bacteria can also survive in environments with limited nutrients.
These traits make B. cepacia contamination in medical devices and liquid pharmaceutical products a significant concern. The bacteria are responsible for the deadly infection outbreaks that prompted the IV flush syringe recalls.
Since B. cepacia is an opportunistic pathogen, it causes severe infections in some patients with pre-existing conditions such as cystic fibrosis. It also affects people with weak immune systems, such as HIV-positive patients, chemotherapy patients, and the elderly.
B. cepacia swiftly adapts to stressful environments, which makes it challenging to target. The bacteria can also thrive in water environments like drinking water, water bodies, and liquids with minimal nutrients.
B. cepacia can survive and multiply in the saline solution in IV flush syringes. This was the main reason the contamination and infection outbreaks were so widespread.
Identifying and detecting the bacteria is challenging because there’s no instant test. It can quickly spread and multiply in a healthcare setting, putting vulnerable patients at higher risk of infection and death.
Over the years, several manufacturers voluntarily recalled defective IV flush syringes for different reasons.
Nurse Assist Inc. announced a voluntary recall of several batches of unexpired IV Flush Syringes on 4th October 2016. The company distributed the recalled syringes between 16th February and 30th September 2016.
The recalled products included:
|Lot Number||Product Code||Description|
|All unexpired lots||1203||IV Flush Syringe, 3ml|
|All unexpired lots||1205||IV Flush Syringe, 5ml|
|All unexpired lots||1210||IV Flush Syringe, 10ml|
|All unexpired lots||1210-BP||IV Flush Syringe, 10ml|
Product Numbers 1210, 1205, and 1203 contained 180 syringes, with six inner cartons, each holding 30 IV flush syringes. Product Number 1210-BP had 400 needles in every case.
The FDA classified the Normal Saline IV Flush Syringe recall as a Class I recall because of the high risk of injury and death. The recall involved 400,000 IV flush syringe units contaminated with the deadly B. cepacia.
BD Medical Flush IV Syringe Recall
BD Medical voluntarily recalled particular BD Pre-Filled Saline Flush syringes and BD PosiFlush Heparin Lock Flush in April 2018.
This move followed concerns that the syringes had S. marcescens bacteria. The CDC discovered the link between BD flush products and severe bloodstream infections in several states.
The recalled products included:
BD PosiFlush Heparin Lock Flush Syringes -Catalog REF Numbers
BD Pre-Filled Saline Syringes – Catalog REF Numbers
Other notable IV flush syringe recall included:
- February 2018
Due to improper packaging, Medline Industries Inc. recalled 90,870 USP 5 mL in 10 mL Syringe ZR syringes.
- August 2015
Covidien LLC recalled 207,876 Monoject 0.9% Saline Flush syringes due to compromised sterility during the packaging process.
- April 2015
MRP, LLC dba AMUSA recalled 200,000 USP Flush Syringes due to wrong expiration dates indicated on the label.
- July 2014
Becton Dickinson & Company recalled 3,088,320 PosiFlush SF Saline Flush syringes due to open seals on some devices.
- August 2013
Covidien LLC recalled 3,565,980 Monoject 100 Units/mL Heparin Flush syringes due to non-sterile water in the needles.
- November 2011
Hospira Inc recalled 5,817,600 USP pre-filled flush syringes due to contamination in the saline fluid.
- November 2010
Covidien LP recalled 1,356,480 MONOJECT Prefill Heparin Flush Syringes due to contamination. The heparin in the syringes was oversulfated, which triggered severe allergic reactions in some people.
- September 2010
Excelsior Medical Corp. recalled 13,734,640 Excelsior Disposable syringes due to possible leakage and compromised sterility.
- July 2007
B. Braun Medical Inc. recalled 1,325,760 Normal Saline syringes due to contamination.
- October 2006
Excelsior Medical Corp. recalled 466,000 Sodium Chloride Flush syringes due to improper labeling.
General Physician Sentiment
Bacteremia infections often trigger life-threatening reactions in the body. One of the most significant concerns is that the condition can advance to septicemia.
Sepsis can be challenging to identify and treat. If left untreated, it can cause organ failure, extensive tissue damage, and death in some cases.
According to the National Institute of General Medical Science, more than 1.7 million people in the US suffer from sepsis yearly, and 28% to 50% of these cases result in fatalities.
In 2011, the US Agency for Healthcare Research and Quality (AHRQ) ranked septicemia as the most expensive medical condition. The hospital costs related to septicemia were over $20 billion that year.
Dr. Amesh Adalja, an infectious disease expert at the Johns Hopkins Center for Health Security, explains why the B. cepacia and S. marcescens are so severe.
He cautions that the main reason the bacteria are so dangerous is that they get injected directly into the bloodstream. There are no barriers that limit entry into the bloodstream.
Most patients reported symptoms such as:
- Elevated heart rate
- Disorientation or confusion
- Shortness of breath
- Sweaty or clammy skin
- Shivering or chills
Brief Lawsuit History
IV Flush Syringe Lawsuits are still in the early stages. There are no notable settlements so far, but legal experts are hopeful for positive outcomes. The manufacturers mentioned in the lawsuits may agree to an out-of-court settlement to avoid the rigorous court processes.
If you or your loved one suffered a blood infection due to contaminated syringes, you deserve compensation for your injuries. Filing an IV Flush Syringe Lawsuit is the best way to hold the manufacturers responsible.
B. Braun Medical Group Lawsuit settlement
Although AM2PAT produced the defective syringes, B. Braun branded and sold the products. This makes B. Braun liable for the harm the contaminated needles caused.
The company agreed to settle the criminal charges filed by the government by paying $7.8 million. $4.8 million was forfeited profit and penalties, while $3 million went to restitution for people affected by the contaminated syringes.
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