BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EXCEL CONTAINER (IV FLUID BAG - 5% DEXTROSE IN LACTATED RING

    MDR report key: 1220963 · Received October 21, 2008

    Report

    Report Number
    1220963
    Event Type
    Malfunction
    Date Received
    October 21, 2008
    Date of Event
    October 10, 2008
    Report Date
    October 21, 2008
    Manufacturer
    B. BRAUN MEDICAL, INC.
    Product Code
    KPE
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CA, US

    Narratives

    Description of Event or Problem · 1

    IV BAG BROKE OPEN; FLUID FOUND ON FLOOR; APPROX 200 ML LEFT IN BAG. BAG RIPPED OPEN AT LOWER SEAM. IV FLUIDS REPLACED, NO PATIENT HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EXCEL CONTAINER (IV FLUID BAG - 5% DEXTROSE IN LACTATED RING BAG, IV KPE B. BRAUN MEDICAL, INC. L7510 J7S507

    Patients

    Seq Age Sex Outcome Treatment
    1 34 YR