BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTEGRON

    MDR report key: 18464257 · Received January 8, 2024

    Report

    Report Number
    3013145340-2024-00012
    Event Type
    Malfunction
    Date Received
    January 8, 2024
    Date of Event
    October 18, 2022
    Report Date
    January 8, 2024
    Manufacturer
    TERRAGENE S.A
    Product Code
    JOJ
    UDI-DI
    07798164679622
    PMA / PMN Number
    K191021
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    ACCORDING TO THE DISTRIBUTOR, THERE WAS NO KNOWN REPORTABLE EVENT THAT OCCURRED. ONE INDICATOR SHOWED BLEEDING OF THE INK AND THE USER HAD TO REPROCESS THE LOAD. DEVICE MALFUNCTION CAUSE THE DEVICE TO FAIL TO PERFORM ITS ESSENTIAL FUNCTION AND COMPROMISE THE DEVICE'S MONITORING EFFECTIVENESS, WHICH COULD CONTRIBUTE TO A SERIOUS INJURY IF IT WERE TO RECUR. ADDITIONALY, THE INK BLEEDING FROM THE INDICATOR COULD STAIN THE STERILIZER'S LOAD AFFECTING THE USABILITY OF THE PROCESSED DEVICES, WHICH COULD ALSO CONTRIBUTE TO A DEATH OR SERIOUS INJURY IF IT WERE TO RECUR.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A CHEMICAL INTEGRATOR SHOWED INK LEAKING AFTER THE STERILIZATION CYCLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    567706 INTEGRON CHEMICAL INDICATOR JOJ TERRAGENE S.A IT26-C B20040 07798164679622

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown