BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STRYKER

    MDR report key: 18437800 · Received January 3, 2024

    Report

    Report Number
    3013145340-2024-00007
    Event Type
    Malfunction
    Date Received
    January 3, 2024
    Date of Event
    September 2, 2022
    Report Date
    January 3, 2024
    Manufacturer
    TERRAGENE S.A
    Product Code
    FRC
    UDI-DI
    07798164678793
    PMA / PMN Number
    K191021
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    NO DEVICE-RELATED DEATHS OR SERIOUS INJURIES WERE INFORMED AND THERE IS NO OBJECTIVE EVIDENCE OF PRODUCT MALFUCTION. HOWEVER, AS NO FURTHER INFORMATION WAS PROVIDED, WE CONSIDER THE POSITIVE READOUT MAY HAVE BEEN CAUSED BY AN INEFFECTIVE STERILIZATION PROCESS OR A BIOLOGICAL INDICATOR MALFUNCTION, WHICH MAY CAUSE THE DEVICE TO FAIL TO PERFORM ITS ESSENTIAL FUNCTION AND COMPROMISE THE STERILIZATION PROCESS MONITORING EFFECTIVENESS. THIS COULD CONTRIBUTE TO DELAY PATIENT TREATMENT AND, HENCE, TO A SERIOUS INJURY IF IT WERE TO RECUR.

    Description of Event or Problem · 0

    USER REPORTED MALFUNCTIONING OF THE AUTOREADER INCUBATOR BECAUSE OF POSITIVE RESULTS OBTAINED WITH THE BIOLOGICAL INDICATOR AFTER STERILIZATION PROCESS IN THE VP4 EQUIPMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1435315 STRYKER BIOLOGICAL INDICATOR FRC TERRAGENE S.A STRYKER SRBI30 UNKNOWN 07798164678793

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown