BD PosiFlush 306514Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00382903065141), received between Apr 2, 2018 and Jun 12, 2018 — classified as 3 injuries, 1 malfunction.

The most frequently reported specific device problem is “Microbial Contamination of Device” (2 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 18, 2026.

Most reported problems

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjuryJun 12, 2018Nonstandard Device

  IT WAS REPORTED THAT A (B)(6) MALE PATIENT WITH A DIAGNOSIS OF NEUROBLASTOMA AND A TUNNELED CENTRAL LINE 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 3ML BD POSIFLUSH¿ HEPARIN LOCK FLUSH SYRINGE, IN 10ML SYRINGE, 100 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 CERTA

  Patient problems: Bacterial Infection

  MAUDE report 7594791 ↗
• InjuryJun 11, 2018Microbial Contamination of Device

  IT WAS REPORTED THAT A (B)(6) FEMALE PATIENT WITH A DIAGNOSIS OF RESPIRATORY FAILURE AND SEPSIS 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 3ML BD POSIFLUSH¿ HEPARIN LOCK FLUSH SYRINGE, IN 10ML SYRINGE, 100 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 TREAT

  Patient problems: Bacterial Infection

  MAUDE report 7589890 ↗
• InjuryJun 6, 2018Nonstandard Device; Microbial Contamination of Device

  IT WAS REPORTED THAT A (B)(6) YEAR OLD, MALE PATIENT WITH A DIAGNOSIS OF MEDULLOBLASTOMA AND A PORT 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 3 ML BD POSIFLUSH¿ HEPARIN LOCK FLUSH SYRINGE, IN 10 ML SYRINGE, 100 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 (B)(4) ABOUT A POTENTIAL EPIDEMIOLOGICAL LINK BETWEEN CATHETER RELATED BLOOD STREAM INFECTIONS AND THE S. MARCESCENS BACTERIUM. SPECIFICALLY, THE (B)(4) IDENTIFIED A POTENTIAL CONNECTION BETWEEN REPORTS OF INFECTION IN A SMALL NUMBER OF PATIENTS CAUSED BY S. MARCESCENS ACROSS MULTIPLE STATES. (B)(4)¿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 FO

  Patient problems: Bacterial Infection

  MAUDE report 7576207 ↗
• MalfunctionApr 2, 2018Crack; Fluid/Blood Leak

  IT WAS REPORTED A BD POSIFLUSH¿ HEPARIN LOCK FLUSH SYRINGE WAS FOUND CRACKED AND EMPTY OF THE MEDICATION. THERE WAS NO REPORT OF EXPOSURE, SERIOUS INJURY OR MEDICAL INTERVENTION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7389741 ↗