BEUDAMED
    FDA Adverse Event Other Summary report: N

    VACUTAINER (BECTON DICKINSON) LUER ADAPTER

    MDR report key: 225941 · Received June 1, 1999

    Report

    Report Number
    MW1016441
    Event Type
    Other
    Date Received
    June 1, 1999
    Report Date
    June 1, 1999
    Manufacturer
    BECTON DICKINSON INFUSION THERAPY SYSTEMS, INC.
    Product Code
    JKA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    WHEN THE BECTON DICKINSON (VACUTAINER) LUER ADAPTER IS USED WITH THE IV CATHETER TIPS TO DRAW BLOOD, HEMOLYSIS OCCURS BECAUSE OF IMPROPER FIT. THIS IS OCCURRING NATIONWIDE IN EMERGENCY ROOMS AS RN'S DRAW BLOOD. RPTR HAS SEEN THIS OCCUR REPEATEDLY OVER AN EXTENDED PERIOD OF TIME. RPTR IS WORKING TO IMPLEMENT A PIECE OF EXTENSION TUBING TO RELEASE THE PRESSURE PRIOR TO THE LUER ADAPTER. THE CORRECTION IS EASY BUT A SLOW PROCESS. RPTR TRACKED MANY, MANY SAMPLES AND IS CONFIDENT OF THIS OCCURRENCE. THE CO HAS CONFIRMED IT, BUT NOW THEIR POSITION/AVAILABILITY HAS CHANGED. THERE IS NO MOTIVATION TO CORRECT SINCE THEY HAVE HAD YEARS OF "DOUBLE PROFITS" SINCE BLOOD IS REDRAWN. MANY, MANY PEOPLE ARE AFFECTED BY THIS OCCURRENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VACUTAINER (BECTON DICKINSON) LUER ADAPTER LUER ADAPTER JKA BECTON DICKINSON INFUSION THERAPY SYSTEMS, INC. * MULTIPLE

    Patients

    Seq Age Sex Outcome Treatment
    1 * Other