BD PosiFlush 306510Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00382903065103), received between Apr 27, 2018 and Jul 30, 2018 — classified as 6 injuries.

The most frequently reported specific device problem is “Microbial Contamination of Device” (3 reports).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• InjuryJul 30, 2018Nonstandard Device

  IT WAS REPORTED THAT A PATIENT CONTRACTED AN INFECTION, HAD A POSITIVE BLOOD CULTURE, WAS HOSPITALIZED, RECEIVED ANTIBIOTICS, AND HAD HER CENTRAL LINE CHANGED. THE USE OF A 5ML BD POSIFLUSH¿ HEPARIN LOCK FLUSH SYRINGE, IN 10ML SYRINGE, 10 USP UNITS/ML WAS ASSOCIATED WITH THIS INCIDENT. OUT OF AN ABUNDANCE OF CAUTION AND IN THE INTEREST OF PUBLIC HEALTH, BD VOLUNTARILY RECALLED CERTAIN LOTS OF BD POSIFLUSH¿ HEPARIN LOCK FLUSH AND BD¿ PRE-FILLED NORMAL SALINE FLUSH SYRINGES DUE TO A POTENTIAL FOR CONTAMINATION WITH SERRATIA MARCESCENS BACTERIUM. BD WAS NOTIFIED BY THE U.S. FOOD AND DRUG ADMINISTRATION (FDA) AND CENTERS FOR (B)(6) ABOUT A POTENTIAL EPIDEMIOLOGICAL LINK BETWEEN CATHETER RELATED BLOOD STREAM INFECTIONS AND THE S. MARCESCENS BACTERIUM. SPECIFICALLY, THE FDA AND (B)(6)IDENTIFIED A POTENTIAL CONNECTION BETWEEN REPORTS OF INFECTION IN A SMALL NUMBER OF PATIENTS CAUSED BY S. MARCESCENS ACROSS MULTIPLE STATES. (B)(6)'S INITIAL INVESTIGATION FOUND THAT AFFECTED PATIENTS HAD RECEIVED TREATMENT USING CERTAIN BD FLUSH PRODUCTS. TO DATE, THERE IS NO EVIDENCE OF BD FLUSH PRODUCT TESTING POSITIVE FOR THIS BACTERIUM. INVESTIGATIONS ARE ONGOING BY BD, FDA, AND (B)(6).

  Patient problems: Bacterial Infection

  MAUDE report 7732419 ↗
• InjuryJul 17, 2018Microbial Contamination of Device

  IT WAS REPORTED THAT A PATIENT CONTRACTED AN INFECTION AFTER USING A 5ML BD POSIFLUSH¿ HEPARIN LOCK FLUSH SYRINGE, IN 10ML SYRINGE, 10 USP UNITS/ML. IT IS UNKNOWN IF MEDICAL INTERVENTION WAS PROVIDED. *OUT OF AN ABUNDANCE OF CAUTION AND IN THE INTEREST OF PUBLIC HEALTH, BD VOLUNTARILY RECALLED CERTAIN LOTS OF BD POSIFLUSH¿ HEPARIN LOCK FLUSH AND BD¿ PRE-FILLED NORMAL SALINE FLUSH SYRINGES DUE TO A POTENTIAL FOR CONTAMINATION WITH SERRATIA MARCESCENS BACTERIUM. BD WAS NOTIFIED BY THE U.S. FOOD AND DRUG ADMINISTRATION (FDA) AND CENTERS FOR DISEASE CONTROL AND PREVENTION (CDC) ABOUT A POTENTIAL EPIDEMIOLOGICAL LINK BETWEEN CATHETER RELATED BLOOD STREAM INFECTIONS AND THE S. MARCESCENS BACTERIUM. SPECIFICALLY, THE FDA AND CDC IDENTIFIED A POTENTIAL CONNECTION BETWEEN REPORTS OF INFECTION IN A SMALL NUMBER OF PATIENTS CAUSED BY S. MARCESCENS ACROSS MULTIPLE STATES. CDC¿S INITIAL INVESTIGATION FOUND THAT AFFECTED PATIENTS HAD RECEIVED TREATMENT USING CERTAIN BD FLUSH PRODUCTS. TO DATE, THERE IS NO EVIDENCE OF BD FLUSH PRODUCT TESTING POSITIVE FOR THIS BACTERIUM. INVESTIGATIONS ARE ONGOING BY BD, FDA, AND CDC.

  Patient problems: Bacterial Infection

  MAUDE report 7696885 ↗
• InjuryJun 28, 2018Microbial Contamination of Device

  IT WAS REPORTED THAT A PATIENT CONTRACTED A SERRATIA MARCESCENS INFECTION POST KNEE SURGERY. HISTORICALLY THE PATIENT HAD KNEE REPLACEMENT SURGERY ON (B)(6) 2015 AND IN (B)(6) 2017 DEVELOPED A STAPH INFECTION THAT LEFT AN OPEN WOUND IN THE SIDE OF THE HIS KNEE. THE PATIENT HAS HAD MANY SURGERIES FOR THIS SINCE. ON (B)(6) 2018, THE PATIENT HAD ANOTHER SURGERY AND DID NOT HEAL. ON (B)(6) 2018, CULTURES WERE POSITIVE FOR SERRATIA MARCESCENS AND NOT STAPH. THE PATIENT HAD AN ADDITIONAL SURGERY ON (B)(6) 2018. THE USE OF A 5ML BD POSIFLUSH¿ HEPARIN LOCK FLUSH SYRINGE, IN 10ML SYRINGE, 10 USP UNITS/ML WAS ASSOCIATED WITH THIS INCIDENT. OUT OF AN ABUNDANCE OF CAUTION AND IN THE INTEREST OF PUBLIC HEALTH, BD VOLUNTARILY RECALLED CERTAIN LOTS OF BD POSIFLUSH¿ HEPARIN LOCK FLUSH AND BD¿ PRE-FILLED NORMAL SALINE FLUSH SYRINGES DUE TO A POTENTIAL FOR CONTAMINATION WITH SERRATIA MARCESCENS BACTERIUM. BD WAS NOTIFIED BY THE U.S. FOOD AND DRUG ADMINISTRATION (FDA) AND (B)(4) ABOUT A POTENTIAL EPIDEMIOLOGICAL LINK BETWEEN CATHETER RELATED BLOOD STREAM INFECTIONS AND THE S. MARCESCENS BACTERIUM. SPECIFICALLY, THE FDA AND (B)(4) IDENTIFIED A POTENTIAL CONNECTION BETWEEN REPORTS OF INFECTION IN A SMA

  Patient problems: Bacterial Infection

  MAUDE report 7646322 ↗
• InjuryJun 12, 2018Nonstandard Device

  IT WAS REPORTED THAT A (B)(6) FEMALE WITH A DIAGNOSIS OF HODGKIN¿S LYMPHOMA AND A PICC LINE IN PLACE HAD A POSITIVE BLOOD CULTURE FOR SERRATIA MARCESCENS ON (B)(6) 2018. THE PATIENT WAS TREATED AND DISCHARGED. THE PFGE PATTERNS FOR THIS INCIDENT ARE INDISTINGUISHABLE FROM THE ORIGINAL CO OUTBREAK PATTERN. THE DEVICE IMPLICATED WITH THIS INCIDENT IS A 5ML BD POSIFLUSH¿ HEPARIN LOCK FLUSH SYRINGE, IN 10ML SYRINGE, 10 USP UNITS/ML. OUT OF AN ABUNDANCE OF CAUTION AND IN THE INTEREST OF PUBLIC HEALTH, BD VOLUNTARILY RECALLED CERTAIN LOTS OF BD POSIFLUSH¿ HEPARIN LOCK FLUSH AND BD¿ PRE-FILLED NORMAL SALINE FLUSH SYRINGES DUE TO A POTENTIAL FOR CONTAMINATION WITH SERRATIA MARCESCENS BACTERIUM. BD WAS NOTIFIED BY THE U.S. FOOD AND DRUG ADMINISTRATION (FDA) AND CENTERS FOR DISEASE CONTROL AND PREVENTION (CDC) ABOUT A POTENTIAL EPIDEMIOLOGICAL LINK BETWEEN CATHETER RELATED BLOOD STREAM INFECTIONS AND THE S. MARCESCENS BACTERIUM. SPECIFICALLY, THE FDA AND CDC IDENTIFIED A POTENTIAL CONNECTION BETWEEN REPORTS OF INFECTION IN A SMALL NUMBER OF PATIENTS CAUSED BY S. MARCESCENS ACROSS MULTIPLE STATES. CDC¿S INITIAL INVESTIGATION FOUND THAT AFFECTED PATIENTS HAD RECEIVED TREATMENT USING CERTAIN BD

  Patient problems: Bacterial Infection

  MAUDE report 7594803 ↗
• InjuryMay 24, 2018Microbial Contamination of Device

  IT WAS REPORTED THAT THE (B)(6) CONFIRMED A CASE OF SERRATIA MARCESCENS BLOODSTREAM INFECTION FROM (B)(6) WITH PFGE PATTERNS INDISTINGUISHABLE FROM THE ORIGINAL CO OUTBREAK PATTERN. THE PATIENT IS A (B)(6) YEAR OLD MALE DIAGNOSED WITH LYMPHOMA AND IS IMMUNOCOMPROMISED WITH AN IMPLANTED PORT THAT WAS ACCESSED IN AN OUTPATIENT INFUSION CLINIC. THE PATIENT PRESENTED TO A HOSPITAL WITH POSITIVE SERRATIA MARCESCENS CULTURE ON (B)(6) 2018, WAS TREATED, AND SUBSEQUENTLY DISCHARGED. THE SPECIFIC TREATMENT PROVIDED IS UNKNOWN. THE DEVICE IMPLICATED WITH THIS INCIDENT IS A 5ML BD POSIFLUSH¿ HEPARIN LOCK FLUSH SYRINGE, IN 10ML SYRINGE, 10 USP UNITS/ML. OUT OF AN ABUNDANCE OF CAUTION AND IN THE INTEREST OF PUBLIC HEALTH, BD VOLUNTARILY RECALLED CERTAIN LOTS OF BD POSIFLUSH¿ HEPARIN LOCK FLUSH AND BD¿ PRE-FILLED NORMAL SALINE FLUSH SYRINGES DUE TO A POTENTIAL FOR CONTAMINATION WITH SERRATIA MARCESCENS BACTERIUM. BD WAS NOTIFIED BY THE U.S. FOOD AND DRUG ADMINISTRATION (FDA) AND (B)(6) ABOUT A POTENTIAL EPIDEMIOLOGICAL LINK BETWEEN CATHETER RELATED BLOOD STREAM INFECTIONS AND THE S. MARCESCENS BACTERIUM. SPECIFICALLY, THE FDA AND (B)(6) IDENTIFIED A POTENTIAL CONNECTION BETWEEN REPORTS OF INFECT

  Patient problems: Bacterial Infection

  MAUDE report 7541269 ↗
• InjuryApr 27, 2018Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT INFECTIONS ASSOCIATED WITH CENTRAL LINES AND THE USE OF A 5 ML BD POSIFLUSH¿ HEPARIN LOCK FLUSH SYRINGE, IN 10 ML SYRINGE, 10 USP UNITS/ML WERE BEING INVESTIGATED BY THE FDA. THERE WAS NO EVIDENCE THAT THE BD DEVICE IS IMPLICATED BUT ALL SOURCES AND COMMON PRODUCTS ARE BEING INVESTIGATED.

  Patient problems: Unspecified Infection

  MAUDE report 7467627 ↗