BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FLASH TUBE

    MDR report key: 33408 · Received June 13, 1996

    Report

    Report Number
    MW1009289
    Event Type
    Malfunction
    Date Received
    June 13, 1996
    Date of Event
    May 25, 1996
    Report Date
    June 4, 1996
    Manufacturer
    MC GAW, INC.
    Product Code
    BRZ
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    VA, US
    Reporter Occupation
    PHARMACIST

    Narratives

    Description of Event or Problem · 1

    AIR ENTERED INTO TUBING DURING A BLOOD TRANSFUSION. AIR WAS DESCRIBED AS ENTERING "HIGH AND MIDWAY UP" IN THE TUBING. AIR ENTERED INTO BLOOD BAG BUT WENT INTO PT. A SECOND TUBING OF SAME LOT HAD THE SAME PROBLEM. A THIRD TUBING OF A DIFFERENT LOT WORKED WELL. (LABEL)

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FLASH TUBE Y-TYPE BLOOD TUBING BRZ MC GAW, INC. F6B098

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR