BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ABBOTT

    MDR report key: 273490 · Received April 6, 2000

    Report

    Report Number
    MW1018648
    Event Type
    Malfunction
    Date Received
    April 6, 2000
    Date of Event
    April 3, 2000
    Report Date
    April 3, 2000
    Manufacturer
    ABBOTT LABORATORIES
    Product Code
    KPE
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    TX, US
    Reporter Occupation
    PHARMACIST

    Narratives

    Description of Event or Problem · 1

    AFTER COMPOUNDING TPN INTO NUTRIMIX 2000 ML EMPTY BAG, UPON FINAL INSPECTION - CLEAR PLASTIC-APPEARING PARTICLE NOTED IN TPN. BAG NOT SENT TO PT - HELD IN PHARMACY FOR INSPECTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ABBOTT 2000 ML NUTRIMIX EMPTY CONTAINER WITH ATTACHED TRANSFER SET KPE ABBOTT LABORATORIES 4425 61178HG01

    Patients

    Seq Age Sex Outcome Treatment
    1 *