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IV Flush Syringe

Manufactured by Texas-based Nurse Assist, Normal Saline IV Flush Syringes are used by health care professionals to clear out patients’ catheters and intravenous lines to ensure the tubes are sterile. But something went wrong in 2016, and the flush syringes themselves apparently transmitted a bacterial infection.

IV Flush Syringe

Used for: Clearing out IV lines and catheters

Made by: Nurse Assist

Risks: Linked to bacterial infection outbreak

Adverse Effects: Patients became sick; some died (cause of death not clear).

Recalled Models: 12 ml IV Flush Syringe with a 3 ml, 5 ml or 10 ml fill. Product codes: 1203, 1205, 1210 and 1210-BP

FDA Approval Status: Cleared through the 510(k) premarket process August 2015

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Nurse Assist flush syringes were implicated in an outbreak of the Burkholderia cepacia bacterial infection found in the blood of 164 patients in 59 medical facilities, such as nursing homes, in five states. According to the Centers for Disease Control and Prevention, seven people died — five in New York and two in Pennsylvania — although it’s undetermined if the causes of those deaths were the infection or underlying conditions or something else.

New Jersey reported the most cases, with 59, followed by New York with 58 and Pennsylvania with 30. The remaining cases were reported in Delaware (4) and Maryland (12).

B. Cepacia Bacteria Linked to Flushes

CDC researcher Dr. Richard B. Brooks told DrugWatch that the CDC has not yet reported the root cause of the contamination, which led to the recall of more than 386,000 IV Flush syringes nationwide on Oct. 4, 2016. The recall was initiated less than two weeks after the Maryland Department of Health and Mental Hygiene first alerted the CDC to a cluster of infections among patients at long-term rehabilitation facilities who were receiving intravenous fluids and/or antibiotics through central venous catheters.

After reviewing patient records and culturing suspect products, investigators quickly discovered that the affected patients were all in skilled nursing facilities supplied by the same pharmacy, which distributed saline flushes from the same manufacturer. On Oct. 3, they found B. cepacia bacteria in sealed saline flushes made at one of the manufacturer’s facilities. The next day, the recall was initiated.

“Quick action and open inter-state collaboration prevented additional cases and identified the outbreak source,” Brooks, a CDC epidemic intelligence service officer assigned to the Maryland Department of Health, said in an email to DrugWatch.

“This investigation demonstrates the need for us to be able to better track compounded medications and medical devices, including saline flush syringes, throughout the manufacturing and distribution process, up to the point at which they are given to individual patients,” Brooks told Infectious Disease News.

Asked by DrugWatch to elaborate on this, Brooks said, “Currently, there is not a good mechanism in place for tracking individual saline flushes to an individual patient. That made determining which patients in this outbreak were at risk for having been exposed to the contaminated flushes challenging. An improved mechanism for tracking flushes and other similar devices might help in more quickly identifying patients who have received a specific product.”

IV Flush Syringes Clear Out Devices

IV Flush Syringes are ubiquitous in medical settings, such as hospitals and clinics.

Nurse Assist prefills each IV Flush Syringe with 0.9 percent 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.

Hospitals use IV Flush Syringes to ensure the lines stay clean and prevents blockage.

Health care providers and patients use these syringes to clear out devices that deliver medicine directly into the veins of a patient through a needle 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.

To flush the IV, nurses and other health care professionals 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. Next, they 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.

Syringe Infection Cause Unknown

But it’s a mystery how syringes that were supposed to be sterilized became contaminated with a bacteria, Burkholderia cepacia, which can be deadly in some immune compromised patients, particularly those with cystic fibrosis and the elderly. Otherwise healthy people who are infected may show no symptoms at all.

“Since the FDA has not reported the root cause of contamination at the manufacturing or sterilizing facilities, it is impossible to say how the syringes became contaminated,” Brooks said. “It is unlikely that the bacteria would have survived properly conducted sterilization with gamma radiation. Therefore, the most likely explanations for contamination include: 1) the syringes somehow failed to undergo sterilization; 2) there was a problem with the sterilization process in such a way that sterilization was not effective; or 3) bacteria were somehow introduced into the saline in the syringes after sterilization.”

Burkholderia cepacia is a bacterium found naturally in river sediments and moist soil around plant roots. It causes rot in certain plants, including garlic and onions. It is adaptable and able to survive in hostile environments, including disinfectants. It can survive for years in water. It is naturally resistant to many common antibiotics. It even uses penicillin as a nutrient. Healthy people are rarely infected by it.

Scanning Electron Micrograph of Burkholderia cepacia.

 
There have been other instances of Burkholderia cepacia being transmitted through contaminated health care products, including mouthwash, nasal spray, liquid stool softener and sublingual probes.

Since Burkholderia cepacia is commonly found in soil and water, Brooks was asked, should consumers be wary of any water-based medical products, even those that are sterilized, in light of what happened here?

No, the researcher said. People need not worry, but they can take precautions.

Outbreaks Called Very Rare

“Fortunately, outbreaks such as the one we investigated are very rare, and regulations that are in place to ensure the safety of medications provide excellent protection for consumers,” he said. “Consumers can check the FDA’s searchable MedWatch website to learn about reported adverse events associated with regulated products. They can also further protect themselves by asking their providers if they are following evidence-based infection control practices, including hand hygiene protocols and safe injection practices.”

The recall involved Normal Saline Flush 12ml IV Flush Syringe with fill volumes of 3ml, 5 ml and 10 ml. It covered lots of product codes 1203, 1205, 1210 and 1210-BP with the manufacturing dates between September 24, 2015 to August 1, 2016. The distribution dates were February 16, 2016 to September 30, 2016.

Symptoms of bloodstream infections include:

  • Fever
  • Chills or shivering
  • Clammy or sweaty skin
  • Confusion or disorientation
  • Shortness of breath
  • Increased heartrate

The CDC advises medical-device distributors, health care facilities and providers to stop using any of the remaining Nurse Assist prefilled saline flush syringes and immediately recover unused syringes from pharmacies, medication carts, preparation and patient-care areas. Also, notify local or state health authorities of any cases of B. cepacia bloodstream infections in patients who received intravenous care at a facility that was using these products and whose symptoms began since Aug. 1, 2016.

In May 2017, nearly eight months after the Nurse Assist syringes were recalled, the FDA issued an advisory notifying manufacturers of non-sterile, water-based drug products of recent recalls linked to Burkholderia cepacia contamination. B. cepacia, the warning said, can be found in pharmaceutical water systems and can survive and multiply in non-sterile, water-based products because it’s resistant to certain preservatives and antimicrobial agents.

Brooks said that advisory wouldn’t have applied to the IV Flush Syringes because they’re sterile.

Drugwatch.com Author

Author

Elaine is a career journalist with a strong desire to learn, explain, and help people. She worked for The Tampa Tribune for 13 years, covering courts and legal issues until the newspaper closed in 2016.

View Sources
  1. Centers for Disease Control and Prevention. (2017, April 19). Multistate Outbreak of Burkholderia cepacia Bloodstream Infections Associated with Contaminated Prefilled Saline Flush Syringes. Retrieved https://www.cdc.gov/hai/outbreaks/b-cepacia-saline-flush/index.html#modalIdString_CDCTable_0
  2. Govan, J.R.W.; Burns, J.L.; and Speert, D.P. (n.d.). Common Questions About Burkholderia cepacia. Retrieved http://users.ugent.be/~tcoenye/q%26a.PDF
  3. Yale School of Medicine, Pediatric Respiratory Medicine. (2006). Burkholderia Cepacia Information Sheet. Retrieved http://www.childrenshospitalofillinois.org/pdfs/specialty-services/cf/germs-infection-control/Burkholderia-Cepacia-Information-Sheet.pdf
  4. Centers for Disease Control and Prevention. (n.d.). Burkholderia cepacia in Healthcare Settings. Retrieved https://www.cdc.gov/hai/organisms/bcepacia.html
  5. Department of Health and Human Services. (2015, August 31). Letter to Nurse Assist re 510(k). Retrieved https://www.accessdata.fda.gov/cdrh_docs/pdf15/K150143.pdf
  6. U.S. Food and Drug Administration. (2017, January 3). Nurse Assist Inc. Recalls Normal Saline Flush IV Syringes Due to Possible Burkholderia Cepacia Bloodstream Infections. Retrieved https://www.fda.gov/MedicalDevices/Safety/ListofRecalls/ucm535293.htm
  7. Nurse Assist. (2016, October 4). Nurse Assist Initiates Voluntary Recall of IV Flush Syringes. Retrieved http://www.nurseassist.com/nurse-assist-initiates-voluntary-recall-of-iv-flush-syringes
  8. Healio Infectious Disease News. (2017, May 2) B. cepacia outbreak in nursing facilities traced to saline flushes. Retrieved http://www.healio.com/infectious-disease/nosocomial-infections/news/online/%7B638f25d8-32b8-40cd-bfb0-96707f06954f%7D/b-cepacia-outbreak-in-nursing-facilities-traced-to-saline-flushes
  9. Pennsylvania Department of Health. (2016, October 5). Pennsylvania Department of Health Investigating 20 Cases of Bacterial Infection Potentially Linked to Prefilled Saline Flush Syringes. Retrieved http://www.prnewswire.com/news-releases/pennsylvania-department-of-health-investigating-20-cases-of-bacterial-infection-potentially-linked-to-prefilled-saline-flush-syringes-300339987.html
  10. U.S. Food and Drug Administration. (2017, May 22). FDA advises drug manufacturers that Burkholderia cepacia complex poses a contamination risk in non-sterile, water-based drug products. Retrieved https://www.fda.gov/Drugs/DrugSafety/ucm559508.htm?source=govdelivery&utm_medium=email&utm_source=govdelivery
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