BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LEUKOCONNECT PRE-STORAGE-RS-2000 TRANSFER PACK

    MDR report key: 2601435 · Received June 5, 2009

    Report

    Report Number
    2601435
    Event Type
    Malfunction
    Date Received
    June 5, 2009
    Date of Event
    April 25, 2009
    Report Date
    June 4, 2009
    Manufacturer
    FENWAL, INC.
    Product Code
    CAK
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MO, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    LEUKOCYTE-REDUCED RED BLOOD CELL BAGS EXHIBITED SLOW LEAKING AROUND SMALL NODULES OF MATERIAL ADHERED TO THE OUTSIDE EDGE OF THE SEGMENT LINES AT THE DISTAL END.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LEUKOCONNECT PRE-STORAGE-RS-2000 TRANSFER PACK SECONDARY FILTRATION BAG CAK FENWAL, INC. A08H27073
    2 LEUKOCONNECT PRE-STORAGE-RS-2000 TRANSFER PACK SECONDARY FILTRATION BAG CAK FENWAL, INC. A08L02293

    Patients

    Seq Age Sex Outcome Treatment
    1