BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALBUMIN (HUMAN) 25%, USP PLASBUMIN-25

    MDR report key: 2171953 · Received July 18, 2011

    Report

    Report Number
    2171953
    Event Type
    Malfunction
    Date Received
    July 18, 2011
    Date of Event
    July 18, 2011
    Report Date
    July 18, 2011
    Manufacturer
    TALECRIS BIOTHERAPEUTICS, INC.
    Product Code
    KPE
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    IL, US

    Narratives

    Description of Event or Problem · 1

    RN HAD PREVIOUSLY SPIKED A BOTTLE OF ALBUMIN 25% 50 GRAMS FROM SAME LOT. SECOND BOTTLE WAS ATTEMPTED TO BE SPIKED AND THE RUBBER PORTION OF THE CAP WENT INTO THE BOTTLE. THE METAL RING HOLDING THE CAP APPEARS TO BE INTACT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ALBUMIN (HUMAN) 25%, USP PLASBUMIN-25 IV CONTAINER KPE TALECRIS BIOTHERAPEUTICS, INC. * 26NJ121

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR