BD PosiFlush 306521Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 00382903065219), received between Apr 27, 2018 and Jun 12, 2018 — classified as 6 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Microbial Contamination of Device” (4 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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• InjuryJun 12, 2018Nonstandard Device; Microbial Contamination of 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 3 ML BD POSIFLUSH¿ HEPARIN LOCK FLUSH SYRINGE, IN 10 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 CER

  Patient problems: Bacterial Infection

  MAUDE report 7594793 ↗
• InjuryJun 11, 2018Nonstandard Device; Microbial Contamination of Device

  IT WAS REPORTED THAT A 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, 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 USI

  Patient problems: Bacterial Infection

  MAUDE report 7589900 ↗
• InjuryJun 6, 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 3 ML BD POSIFLUSH¿ HEPARIN LOCK FLUSH SYRINGE, IN 10 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

  Patient problems: Bacterial Infection

  MAUDE report 7576082 ↗
• InjuryMay 24, 2018Nonstandard Device; Microbial Contamination of Device

  IT WAS REPORTED THAT THE (B)(4) 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 3ML 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)(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 INFEC

  Patient problems: Bacterial Infection

  MAUDE report 7541272 ↗
• InjuryMay 1, 2018Insufficient Device Problem Information

  IT WAS REPORTED THAT A PATIENT CONTACTED A SERRATIA MARCESCENS AFTER USING A 3 ML BD POSIFLUSH¿ HEPARIN LOCK FLUSH SYRINGE, IN 10 ML SYRINGE, 10 USP UNITS/ML. THE CDC INDICATED PRELIMINARY INFORMATION FROM THE MN PUBLIC HEALTH LAB SHOWS THE PFGE OF THIS ISOLATE IS A MATCH TO THE OUTBREAK STRAIN. THE CDC RECEIVED THIS CLINICAL ISOLATE AND PLAN ON REPEATING THE PFGE AS WELL. AS OF 5/1/2018 THE FOLLOWING CLINICAL INFORMATION HAS BEEN PROVIDED: - THE PATIENT HAS A DOUBLE LUMEN TUNNELED CVC AND RECEIVED NUMEROUS MEDICATIONS VIA A HOME HEALTH AGENCY. - THE PATIENT RECEIVED REGULAR TPN FOR SHORT GUT SYNDROME. - BLOOD CULTURE DATE (B)(6) 2018: POSITIVE FOR S. MARCESCENS. - ADMINISTRATION DATES FOR THE FOLLOWING LOT NUMBERS ARE: LOT #: 721481N (B)(6) 2018: 30 EACH (B)(6) 2018: 30 EACH (B)(6) 2018: 30 EACH (B)(6) 2018: 30 EACH (B)(6) 2018: 30 EACH LOT #: 726571N (B)(6) 2018: 30 EACH (B)(6) 2018: 30 EACH MN PLANS TO SEND SOME PRODUCT FROM EACH OF THESE LOTS TO CDC FOR TESTING, EXCEPT FOR HEPARIN LOT NUMBER 721481N (NO REMAINING PRODUCT), AND THIS PRODUCT WAS LAST ADMINISTERED ON (B)(6) 2018.

  Patient problems: Bacterial Infection

  MAUDE report 7478304 ↗
• MalfunctionApr 27, 2018Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT INFECTIONS ASSOCIATED WITH CENTRAL LINES AND THE USE OF A 3 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 7467624 ↗
• InjuryApr 27, 2018Loose or Intermittent Connection

  IT WAS REPORTED THAT INFECTIONS ASSOCIATED WITH CENTRAL LINES AND THE USE OF A 3 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: No Known Impact Or Consequence To Patient

  MAUDE report 7467623 ↗
• MalfunctionApr 27, 2018Insufficient Device Problem Information

  IT WAS REPORTED THAT INFECTIONS ASSOCIATED WITH CENTRAL LINES AND THE USE OF A 3 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 7467621 ↗