BEUDAMED
    FDA Adverse Event Other Summary report: N

    COMPLY STEAM INTEGRATOR

    MDR report key: 559260 · Received February 27, 2004

    Report

    Report Number
    559260
    Event Type
    Other
    Date Received
    February 27, 2004
    Date of Event
    February 27, 2004
    Report Date
    February 27, 2004
    Manufacturer
    3M MEDICAL COMPANY
    Product Code
    JOJ
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    VT, US

    Narratives

    Description of Event or Problem · 1

    CLASS 5 STERILIZATION INTEGRATOR - 3M 1243 COMPLY STERIGAGUE - DID NOT PERFORM AS DESIGNED. INTEGRATOR FAILED TO CHANGE COLOR ALTHOUGH OTHER INTEGRATORS IN THE SAME STERILIZATION LOAD DID CHANGE.STERILIZER PRINT-OUT OF STERILIZER LOAD CONFIRMED THAT PARAMETERS FOR STERILIZATION HAD BEEN MET. THE PRODUCT ON WHICH THIS INTEGRATOR HAD BEEN USED WAS REPROCESSED. THERE WAS NO PATIENT INJURY INVOLVED SINCE DEVICE WAS NOT USED ON PATIENT. THIS REPORT IS MADE WITH THE REALIZATION THAT THE POTENTIAL FOR HARM TO PATIENTS EXISTS WHEN STERILIZATION CONTROL DEVICES FAIL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COMPLY STEAM INTEGRATOR STEAM INTEGRATOR JOJ 3M MEDICAL COMPANY 3M 1243 2009-01-JM

    Patients

    Seq Age Sex Outcome Treatment
    1 * NO OTHER THERAPIES