BEUDAMED
    FDA Adverse Event Other Summary report: N

    INTRAVIA CONTAINER, EMPTY 150 ML CAPACITY

    MDR report key: 2299738 · Received October 12, 2011

    Report

    Report Number
    MW5022645
    Event Type
    Other
    Date Received
    October 12, 2011
    Report Date
    October 12, 2011
    Manufacturer
    BAXTER HEALTHCARE CORP.
    Product Code
    KPE
    Report Source
    Voluntary report
    Reporter Location
    OH, US
    Reporter Occupation
    PHARMACIST

    Narratives

    Description of Event or Problem · 1

    BAXTER INTRAVIA 150ML EMPTY CONTAINER SHOWED VISUAL PARTICULATES WHEN FLUID IS ADDED TO BAG. MULTIPLE BAGS OF THE SAME LOT NUMBER YIELDED VISIBLE HAIR-LIKE FRAGMENTS THAT APPEAR TO BE MADE OF PVC.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INTRAVIA CONTAINER, EMPTY 150 ML CAPACITY EMPTY BAG KPE BAXTER HEALTHCARE CORP. UR11A13073

    Patients

    Seq Age Sex Outcome Treatment
    1