BD PosiFlush 306511Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00382903065110), received between Jun 11, 2018 and Jun 11, 2018 — classified as 3 injuries.

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 16, 2026.

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryJun 11, 2018Nonstandard Device

  IT WAS REPORTED THAT A (B)(6) 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 5 ML BD POSIFLUSH¿ HEPARIN LOCK FLUSH SYRINGE, IN 5 ML 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 US

  Patient problems: Unspecified Infection

  MAUDE report 7589903 ↗
• InjuryJun 11, 2018Microbial Contamination of Device

  IT WAS REPORTED THAT A (B)(6) YEAR OLD 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 5 ML BD POSIFLUSH¿ HEPARIN LOCK FLUSH SYRINGE, IN 5 ML 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)(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 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 DA

  Patient problems: Bacterial Infection

  MAUDE report 7589886 ↗
• InjuryJun 11, 2018Nonstandard Device; Microbial Contamination of Device

  IT WAS REPORTED THAT A (B)(6), 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 5 ML BD POSIFLUSH¿ HEPARIN LOCK FLUSH SYRINGE, IN 5 ML 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 FLUSH P

  Patient problems: Bacterial Infection

  MAUDE report 7589877 ↗