BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CRYOMACS FREEZING BAG

    MDR report key: 5471815 · Received March 1, 2016

    Report

    Report Number
    3005290010-2016-00051
    Event Type
    Malfunction
    Date Received
    March 1, 2016
    Date of Event
    February 1, 2016
    Report Date
    March 1, 2016
    Manufacturer
    MILTENYI BIOTEC GMBH
    Product Code
    OVG
    PMA / PMN Number
    BK090020
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE FAILED PRIOR TO USE - THERE WAS A LEAK.

    Description of Event or Problem · 1

    THE CUSTOMER COMPLAINED THEY HAD A CRACK IN A Y CONNECTOR IN THEIR CRYOMACS FREEZING BAG (500 ML). THE CRYOMACS BAG WAS NOT CRYOPRESERVED AND THERE WAS ONLY A VERY SMALL LOST OF THE CELL SAMPLE. THERE IS STILL SUFFICIENT CELLULAR MATERIAL LEFT FOR TRANSPLANTATION. THERE WAS NO RISK TO THE PATIENT. THIS EVENT OCCURRED AT: (B)(6).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    128675 CRYOMACS FREEZING BAG CRYOMACS FREEZING BAG OVG MILTENYI BIOTEC GMBH 6150914017

    Patients

    Seq Age Sex Outcome Treatment
    1