BEUDAMED
    FDA Adverse Event Other Summary report: N

    TPN BAG

    MDR report key: 44566 · Received October 24, 1996

    Report

    Report Number
    MW1010147
    Event Type
    Other
    Date Received
    October 24, 1996
    Date of Event
    October 15, 1996
    Report Date
    October 16, 1996
    Manufacturer
    SECURE MEDICAL PRODUCTS, INC.
    Product Code
    KPE
    Report Source
    Voluntary report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE ENTIRE MIDDLE POINT CAME OFF OF THE BAG, SPILLING THE TPN SOLUTION EVERYWHERE, DURING THE INITIATION OF THE CONTINUOUS INFUSION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TPN BAG PARENTERAL NUTRITION BAG KPE SECURE MEDICAL PRODUCTS, INC. * *

    Patients

    Seq Age Sex Outcome Treatment
    1 * Other