BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BRAUN

    MDR report key: 1180472 · Received September 29, 2008

    Report

    Report Number
    MW5008482
    Event Type
    Injury
    Date Received
    September 29, 2008
    Date of Event
    September 29, 2008
    Report Date
    September 29, 2008
    Manufacturer
    B.BRAUN MEDICAL INC.
    Product Code
    KPE
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    GA, US
    Reporter Occupation
    PHARMACIST

    Narratives

    Description of Event or Problem · 1

    EVA DUAL CHAMBER MIXING CONTAINER FOR GRAVITY TRANSFER REF. 2112404 PRODUCT CODE USC3031. WHILE PREPARING A TPN, THE LIPID SIDE RUBBER INJECTION PORT POPPED OFF AND SPILLED THE ENTIRE LIPID CONTENT OUT ONTO THE FLOOR. MAY HAVE BEEN DUE TO HEAT ON THE RUBBER LOOSENING IT TO CAUSE IT TO POP OFF.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BRAUN EVA DUAL CHAMBER MIXING CONTAINER KPE B.BRAUN MEDICAL INC. USC3031 2112404

    Patients

    Seq Age Sex Outcome Treatment
    1 Disability