BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    30 - 70 ML CELL FREEZE CRYOGENIC STORAGE CONTAINER

    MDR report key: 10583752 · Received September 24, 2020

    Report

    Report Number
    1066733-2020-00012
    Event Type
    Malfunction
    Date Received
    September 24, 2020
    Date of Event
    June 29, 2020
    Report Date
    September 24, 2020
    Manufacturer
    CHARTER MEDICAL, LTD.
    Product Code
    LPZ
    PMA / PMN Number
    BK100049
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    501

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINT SAMPLE WAS NOT RETURNED FOR INVESTIGATION. THE USER PROVIDED A PICTURE, WHICH INDICATED A POSSIBLE FILM CRACK BELOW ONE OF THE BAG PORTS.

    Description of Event or Problem · 1

    THE USER REPORTED A CRYO BAG BREAK DURING THE THAWING PROCESS. A FILM CRACK WAS REPORTED AT THE BASE OF A BAG PORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1044687 30 - 70 ML CELL FREEZE CRYOGENIC STORAGE CONTAINER 30 - 70 ML CELL FREEZE CRYOGENIC STORAGE CONTAINER LPZ CHARTER MEDICAL, LTD. CF-250 159202

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR