BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BD POSIFLUSH

    MDR report key: 509043 · Received January 29, 2004

    Report

    Report Number
    2134319-2004-00001
    Event Type
    Injury
    Date Received
    January 29, 2004
    Date of Event
    December 30, 2003
    Report Date
    January 27, 2004
    Manufacturer
    BD MEDICAL SYSTEM
    Product Code
    NGT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHARMACIST

    Narratives

    Description of Event or Problem · 1

    PHARMMICIST AT HOME CARE FACILITY REPORTED THAT THREE PATIENTS HAD DEVELOPED AN INFECTION AND INDICATED THAT THE BD FLUSH SYRINGES WERE ONE ITEM THAT THEY HAD IN COMMON. THE ORGANISM WAS IDENTIFIED AS ENTEROBACTOR CLOACAE. THE PHARMACIST ALSO INDICATED THAT THEY DID NOT HAVE ANY SPECIFIC INDICATION OF A PROBLEM WITH THE SYRINGES BUT WERE ATTEMPTING TO RULE THEM OUT AS A POSSIBLE CAUSE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BD POSIFLUSH 100 U/ML 5ML FILL IN 5ML, HEPARIN LOCK FLUSH SYRINGE NGT BD MEDICAL SYSTEM NA 318921A

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Required Intervention