BD PosiFlush 306545Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 00382903065455), received between Jun 5, 2018 and Sep 13, 2026 — classified as 4 injuries, 6 malfunctions.

The most frequently reported specific device problem is “Device Markings/Labelling Problem” (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 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 13, 2026Material Integrity Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50747880 ↗
• MalfunctionAug 11, 2023Device Markings/Labelling Problem; Device Markings/Labelling Problem

  IT WAS REPORTED THAT THE BD POSIFLUSH¿ NORMAL SALINE SYRINGE LABELING WAS MISSING ON SYRINGE. THE FOLLOWING WAS RECEIVED BY THE INITIAL REPORTER: THE CUSTOMER COMPLAINED THAT NO LABELLING ON THE SYRINGE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17507352 ↗
• MalfunctionMay 16, 2023Wrong Label; Wrong Label

  IT WAS REPORTED THAT THE BD POSIFLUSH¿ SP SYRINGES WERE LABELED AS HEPARIN SYRINGES ON THE CASE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "WHEREVER THESE ARE PRODUCED MADE THE MISTAKE, INSIDE THE CASES LABELED HEPARIN ARE ALL SALINE FLUSHES. THE BOX THAT CAME IN TODAY¿S ORDER CARDBOARD WAS DAMAGED A LITTLE AND SAW SALINE BOXES INSIDE OF THE CARDBOARD LABELED HEPARIN.".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16943012 ↗
• MalfunctionApr 15, 2022Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED WHILE USING 5 ML BD POSIFLUSH¿ NORMAL SALINE SYRINGE, IN 10 ML SYRINGE FOREIGN MATTER WAS FOUND IN THE FLUID PATHWAY. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CUSTOMER HAS A CONTAMINATED FLUSH SYRINGE WITH SOME TYPE OF FOREIGN SUBSTANCE IN THE SOLUTION

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14121619 ↗
• MalfunctionFeb 10, 2020Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT THE BD SYRINGE 5ML SALINE FLUSH HAD A DEFORMED PLUNGER FOUND BEFORE USE. VERBATIM: ¿COMPLAINT FROM REPORTING FACILITY . THE USER COMPLAINED THAT THE PLUNGER WAS DEFORMED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9688232 ↗
• MalfunctionSep 30, 2019Device Markings/Labelling Problem; Device Markings/Labelling Problem

  IT WAS REPORTED THAT LABEL ERROR OCCURRED BEFORE USE WITH A SYRINGE 5ML SALINE 5ML FILL. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, "THE LABEL ON THE SHIPPING BOX DID NOT MATCH WHAT WAS ON THE PRODUCT BOX RECEIVED. OPENED BOX OF 5 ML SALINE FLUSHES MANUFACTURER REORDER #306545. HEPARIN FLUSHES WERE INSIDE THE BOX. THE BOX WAS SEALED."

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9136117 ↗
• 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 5 ML BD POSIFLUSH¿ NORMAL SALINE SYRINGE, IN 10 ML SYRINGE.

  Patient problems: Bacterial Infection

  MAUDE report 7594801 ↗
• InjuryJun 11, 2018Insufficient Device Problem Information

  IT WAS REPORTED THAT A (B)(6) YEAR OLD 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 5 ML BD POSIFLUSH¿ NORMAL SALINE SYRINGE, IN 10 ML SYRINGE.

  Patient problems: Bacterial Infection

  MAUDE report 7589892 ↗
• InjuryJun 11, 2018Insufficient Device Problem Information

  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¿ NORMAL SALINE SYRINGE, IN 10 ML SYRINGE.

  Patient problems: Bacterial Infection

  MAUDE report 7589878 ↗
• InjuryJun 5, 2018Microbial 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¿ NORMAL SALINE SYRINGE, IN 10 ML SYRINGE. 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, THER

  Patient problems: Bacterial Infection

  MAUDE report 7571842 ↗