BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CRYOCYTE FREEZING CONTAINER WITH LABEL POCKET

    MDR report key: 211472 · Received February 19, 1999

    Report

    Report Number
    2030437-1999-00001
    Event Type
    Malfunction
    Date Received
    February 19, 1999
    Date of Event
    January 19, 1999
    Report Date
    January 22, 1999
    Manufacturer
    NEXELL THERAPEUTICS, INC.
    Product Code
    KSR
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    A CRYOCYTE CONTAINER HAD BEEN FOUND BROKEN WHEN REMOVED FROM LIQUID NITROGEN STORAGE. THE CUSTOMER WAS USING A "MEDICATION INJECTION PLUG FOR BLOOD BAG" FOR FILLING THE CONTAINER AND INCLUDING IT WHEN FREEZING. THE CORD BLOOD WITHIN THE CONTAINER WAS LOST.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CRYOCYTE FREEZING CONTAINER WITH LABEL POCKET FREEZING CONTAINER KSR NEXELL THERAPEUTICS, INC. 4R9951 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN