BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EXACTA-MIX EMPTY EVA CONTAINER

    MDR report key: 1577012 · Received January 5, 2010

    Report

    Report Number
    1577012
    Event Type
    Malfunction
    Date Received
    January 5, 2010
    Date of Event
    January 4, 2010
    Report Date
    January 5, 2010
    Manufacturer
    BAXA CORPORATION
    Product Code
    KPE
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    TN, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    TPN VIA INFUSION PUMP WAS BEING ADMINISTERED TO INFANT. RN FOUND TPN LEAKING FROM PORT. BAG REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EXACTA-MIX EMPTY EVA CONTAINER TPN BAG KPE BAXA CORPORATION * 736780

    Patients

    Seq Age Sex Outcome Treatment
    1 3 MO