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The Normal Saline Flush is a plastic IV Flush Syringe manufactured by Nurse Assist, a company based in Haltom City, Tex. Healthcare professionals and patients use the IV Flush Syringe to clear out intravenous lines or catheters used for medicine or other liquids. This ensures the IV tube remains sterile and clean.
The U.S. Food and Drug Administration cleared the Nurse Assist Normal Saline Flush through the 510(k) premarket process in August 2015. Under the 510(k), devices may go to market without rigorous clinical trials if they are "substantially equivalent" to a device previously sold.
On October 4, 2016, Nurse Assist announced a voluntary recall on all unexpired lots of IV Flush Syringes because of a "potential link to Burkholderia cepacia bloodstream infections." IV Flush Syringe lawyers are investigating potential lawsuits on behalf of people who suffered potentially deadly bacterial infections.
Most patients typically encounter an IV Flush Syringe in a hospital or clinic. Nurse Assist prefills each IV Flush Syringe with 0.9% Sodium Chloride — a mixture of salt and water — which is compatible with body fluids and tissues. It sells these plastic syringes in three different doses: a 3 ml fill, 5 ml fill and 10 ml fill for a 12 ml syringe.
Health care professionals and patients use these syringes to flush devices with IV lines or catheters. Hospitals and clinics use them before and after starting IV medication drips or fluids in patients. This ensures the lines stay clean and prevents blockage. Doctors use sodium chloride for a number of medical uses, and the intravenous formula is the most common preparation.
Uses for IV Flush Syringes
To flush the IV, health care professionals — typically nurses — clean the IV port and connect the IV Flush Syringe to it. Then, they slowly pull back on the syringe plunger until a small amount of blood if visible. After, they slowly inject the flush solution into the IV or catheter. At this time, the nurse may start a medication drip. Before beginning another medication in the line, they will flush it again.
In some cases, patients may receive IV therapy or use catheters at home that may need flushing. Doctors or nurses will explain the process. If the tubing becomes blocked, it means the medicine is not flowing and caregivers or patients should contact a doctor immediately.
State agencies linked an outbreak of B. cepacia to Nurse Assist Normal Saline IV Flush Syringes, and the company announced a recall in October 2016. Maryland was the first to report the outbreak in a nursing home. Nurse Assist uses gamma radiation to sterilize the syringes, but the Pennsylvania Department of Health tested the syringes and found B. cepacia contamination.
Maryland, Pennsylvania and New Jersey originally reported 33 infections. Since then, the verified number has grown to 162, according to the latest numbers from the CDC. The latest numbers from January 18, 2017 include 7 deaths. Doctors have not yet verified if these people died from the infection or other ailments.
"Bloodstream infections linked to B. cepacia can be quite serious," Dr. Karyl Rattay, the director of the Delaware Department of Health and Social Services told Becker's Clinical Control and Infection Quality. "We are encouraging all medical providers to determine if they have used any of the potentially contaminated products and be vigilant in testing to identify such infections in patients who may have been exposed and are acutely ill. We are continuing to work closely with the CDC and other federal agencies as this situation evolves."
B. cepacia is a group of bacteria that is normally found in soil and water. It may be transmitted from person-to-person, environmental exposure and contact with contaminated surfaces — such as a syringe. People with normal immune systems don’t typically have a problem with the bacteria, but those with illnesses or weak immune systems are susceptible. If the bacteria enter the bloodstream, it can cause sepsis which can be life threatening.
People at Risk Include:
Symptoms of B. cepacia infection include cough, congestion, difficulty breathing and fever. If the infection is serious, the fever will be high and other symptoms will be more severe. Doctors diagnose the infection by culturing the bacteria in a lab from infected tissues.
Health care professionals treat bacterial infections with antibiotics. However, B. cepacia can be dangerous because it is resistant to many antibiotics. Doctors may try a number of different medications depending on the patient. Treatment may require hospitalization. About 42 percent of people who contract the infection typically die from it.
In addition to possible infections, people may suffer some side effects from the IV flushing process or sodium chloride. For example, if air enters the tube or catheter from the syringe prior to flushing, patients may suffer an air embolism. An air embolism is an air bubble in the blood that can lead to stroke, death and organ problems. Some people may also have allergic reactions to sodium chloride, but side effects from the flushing solution are rare.
On October 4, 2016, Nurse Assist initiated a voluntary recall of 386,175 Normal Saline Flush IV Syringes in the U.S. Nurse Assist manufactured the affected products between September 24, 2015 to August 1, 2016. The company distributed the syringes from February 16, 2016 to September 30, 2016.
The FDA classified the recall as a Class I recall on January 4, 2017. A Class I recall is the most serious type, meaning these devices may cause serious injury or death.
The recall affects the following products:
Nurse Assist is currently investigating the infection link with the Centers for Disease Control and Prevention (CDC), the FDA and state health departments. The company urges health care providers to discontinue use of affected products until it finishes the investigation.
Because a number of patients may be have contracted a B. cepacia infection from Nurse Assist IV Flush Syringes, lawyers are investigating potential lawsuits against Nurse Assist. In these type of device lawsuits, plaintiffs accuse companies of wrongful death, negligence, manufacturing a defective product and knowingly selling a faulty product.