BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BAXTER VIAFLEX TPN BAG

    MDR report key: 585489 · Received March 24, 2005

    Report

    Report Number
    MW1034998
    Event Type
    Malfunction
    Date Received
    March 24, 2005
    Date of Event
    March 24, 2005
    Report Date
    March 24, 2005
    Manufacturer
    *
    Product Code
    KPE
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    TX, US
    Reporter Occupation
    PHARMACIST

    Narratives

    Description of Event or Problem · 1

    ONE LITER BAG. TECH WAS MIXING TPN BAG. UPON COMPLETION SHE WAS CLAMPING THE TUBING IN THE MIDDLE AND NOTICED HAIR ON THE INSIDE OF TUBING. ALL BAGS OF THAT LOT # ISOLATED AND RPTR REMIXED ALL TPN FOR PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BAXTER VIAFLEX TPN BAG TPN BAG KPE * * P138925

    Patients

    Seq Age Sex Outcome Treatment
    1 * Other