BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EVA MIXING CONTAINER

    MDR report key: 9124426 · Received September 25, 2019

    Report

    Report Number
    MW5090058
    Event Type
    Malfunction
    Date Received
    September 25, 2019
    Date of Event
    September 24, 2019
    Report Date
    September 24, 2019
    Manufacturer
    B. BRAUN MEDICAL INC.
    Product Code
    KPE
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NY, US
    Reporter Occupation
    PHARMACIST

    Narratives

    Description of Event or Problem · 1

    BRAUN - 2000 ML SINGLE CHAMBER BAG (2112349) THESE BAGS WERE FILLED WITH HYDRATION SOLUTIONS, AND THERE IS A LEAK IN TWO OF THE BAGS IN THE EXACT SAME PLACE. (AT THE TOP OF THE VERTICAL LINE BETWEEN THE B AND BRAUN). FDA SAFETY REPORT ID# (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    909526 EVA MIXING CONTAINER CONTAINER, I.V KPE B. BRAUN MEDICAL INC. 2112349 19C11
    909527 EVA MIXING CONTAINER CONTAINER, I.V KPE B. BRAUN MEDICAL INC. 2112349

    Patients

    Seq Age Sex Outcome Treatment
    1 1 YR