BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EXACTAMIX EVA CONTAINER

    MDR report key: 1523469 · Received November 5, 2009

    Report

    Report Number
    MW5013364
    Event Type
    Injury
    Date Received
    November 5, 2009
    Date of Event
    October 1, 2009
    Report Date
    October 28, 2009
    Manufacturer
    BAXA CORPORATION
    Product Code
    KPE
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MN, US
    Reporter Occupation
    PHARMACIST

    Narratives

    Description of Event or Problem · 1

    FILLED TPN INFUSION BAG ON DELIVERY CART FOUND LEAKING FROM SPLIT OR CUT NEAR BAG SEAM. PRODUCT HAS RECENTLY CHANGED TO A NEW MATERIAL/DESIGN, NOW WITH TWO LEAKS IN OUR FIRST MONTH OF USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EXACTAMIX EVA CONTAINER TPN SOLUTION BAG (2 LITER SIZE) KPE BAXA CORPORATION H938 740 3

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention