BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CRYOMACS FREEZING BAG 50 ML

    MDR report key: 5018602 · Received August 5, 2015

    Report

    Report Number
    3005290010-2015-00008
    Event Type
    Malfunction
    Date Received
    August 5, 2015
    Date of Event
    July 10, 2015
    Report Date
    August 5, 2015
    Manufacturer
    MILTENYI BIOTEC GMBH
    Product Code
    KSR
    PMA / PMN Number
    BK090020
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    NA.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT 5 OUT OF 10 CRYOMACS FREEZING BAGS 50 ML EXHIBITED CRACKING AND BREACHING OF INTEGRITY UPON THAWING. THE CRYOMACS FREEZING BAGS WERE USED IN DEVELOPMENTAL UPSTREAM PROCESS, THEREFORE, NO PATIENT TREATMENT WAS AFFECTED. THE EVENT HAPPENED AT: (B)(6).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    517773 CRYOMACS FREEZING BAG 50 ML CRYOMACS FREEZING BAG 50 ML KSR MILTENYI BIOTEC GMBH FREEZING BAG 50 ML 6130130002

    Patients

    Seq Age Sex Outcome Treatment
    1