BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PALL TRANSFER/FREEZING BAG SET

    MDR report key: 2923299 · Received October 5, 2006

    Report

    Report Number
    2013342-2006-00004
    Event Type
    Malfunction
    Date Received
    October 5, 2006
    Date of Event
    September 1, 2006
    Report Date
    September 5, 2006
    Manufacturer
    PALL MEDSEP
    Product Code
    KSR
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVAL STARTED, BUT NOT YET COMPLETED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT CRACKS WERE OBSERVED IN THE FREEZER BAG DURING PROCESSING OF A STEM CELL UNIT, ALLOWING THE CORD BLOOD PRODUCT TO LEAK OUT OF THE BAG.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PALL TRANSFER/FREEZING BAG SET KSR: EMPTY CONTAINER FOR THE COLLECTION AND PROCESSING OF BLOOD AND BLOOD COMPON KSR PALL MEDSEP 791-02 BATCH#0115

    Patients

    Seq Age Sex Outcome Treatment
    1