BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BLOOD BAG, NEEDLE

    MDR report key: 33220 · Received May 24, 1996

    Report

    Report Number
    MW4001319
    Event Type
    Malfunction
    Date Received
    May 24, 1996
    Report Date
    June 24, 1994
    Manufacturer
    MILES, INC.
    Product Code
    KSR
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    DC, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    UPON USING BLOOD BAGS IN THE PAST AND PRESENT IN THE BLOOD DONOR CTR, RPTR HAS FOUND THAT THE NEEDLE USED BY THIS CO IS OF VERY POOR QUALITY. AS A RESULT, THE NUMBER OF TRAUMATIC PHLEBOTOMIES AND UNSUCCESSFUL BLOOD UNITS HAVE INCREASED. A LARGE NUMBER OF DONORS HAVE MENTIONED THE DIFFERENCE IN THESE NEEDLES COMPARED TO ANOTHER CO'S NEEDLE RPTR HAS USED IN THE PAST. IN TURN, RPTR IS LOOKING OUT FOR THE DONORS COMFORT AND A GREATER NUMBER OF TRANSFUSABLE BLOOD DONATIONS COLLECTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BLOOD BAG, NEEDLE BLOOD BAG, NEEDLE KSR MILES, INC. 746-74

    Patients

    Seq Age Sex Outcome Treatment
    1 NA