BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CRYOMACS FREEZING BAG 250

    MDR report key: 11397424 · Received March 2, 2021

    Report

    Report Number
    3005290010-2021-00004
    Event Type
    Malfunction
    Date Received
    March 2, 2021
    Date of Event
    December 24, 2020
    Report Date
    March 1, 2021
    Manufacturer
    MILTENYI BIOTEC B.V. & CO. KG
    Product Code
    KSR
    UDI-DI
    04049934000287
    PMA / PMN Number
    BK090020
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SI
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED A CRYOMACS FREEZING BAG 250 (200-074-401; 7200500219) THAT BROKE DURING THAWING. THE PATIENT WAS TREATED WITH BACKUP MATERIAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    299394 CRYOMACS FREEZING BAG 250 CRYOMACS FREEZING BAG 250 KSR MILTENYI BIOTEC B.V. & CO. KG 7200500219 04049934000287

    Patients

    Seq Age Sex Outcome Treatment
    1