BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    75-ML CELL FREEZE CRYOGENIC STORAGE CONTAINER

    MDR report key: 10870818 · Received November 19, 2020

    Report

    Report Number
    1066733-2020-00016
    Event Type
    Malfunction
    Date Received
    November 19, 2020
    Date of Event
    October 23, 2020
    Report Date
    November 19, 2020
    Manufacturer
    CHARTER MEDICAL, LTD.
    Product Code
    LPZ
    PMA / PMN Number
    BK06000042
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINT SAMPLE WAS NOT RETURNED FOR INVESTIGATION. THERE WAS NO AVAILABLE EVIDENCE TO DETERMINE THE ROOT CAUSE.

    Description of Event or Problem · 1

    A BAG LEAKAGE WAS REPORTED AT THE END OF THE THAW PROCESS. CELLS WERE FOUND TO HAVE LEAKED INTO A STERILE SECONDARY BAG. A CRACK WAS OBSERVED TOWARDS THE BOTTOM OF THE BAG.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1338003 75-ML CELL FREEZE CRYOGENIC STORAGE CONTAINER 75-ML CELL FREEZE CRYOGENIC STORAGE CONTAINER LPZ CHARTER MEDICAL, LTD. CML-75LN 152573

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR