BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COMPLY STERIGAGE

    MDR report key: 3840281 · Received April 8, 2014

    Report

    Report Number
    3840281
    Event Type
    Malfunction
    Date Received
    April 8, 2014
    Date of Event
    April 7, 2014
    Report Date
    April 8, 2014
    Manufacturer
    3M COMPANY
    Product Code
    JOJ
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    FL, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    THE 3M COMPLY STERIGAGE CLASS 5 STEAM CHEMICAL INTEGRATORS DID NOT MEET THE PASS REQUIREMENT WINDOW. THE SLIDING FACE ON THE INTEGRATOR STOPPED IN THE REJECT AREA OF THE WINDOW. THERE WAS NO IMPACT TO PATIENT CARE BECAUSE THE SCRUBS SAW THAT THE INDICATOR DID NOT PASS AND RE-SET UP THE STERILE FIELD. STERILE PROCESSING: "I BELIEVE THERE IS A REASONABLE CHANCE THAT THE REJECT WAS RECEIVED IN ERROR BECAUSE WE WERE RUNNING A NEW CYCLE IN OUR STERILIZERS WITH A LIMITED DRY TIME; HOWEVER, THE EXPOSURE TIME OF 4 MINUTES AT 270 DEGREE F WAS MET.====================== MANUFACTURER RESPONSE FOR STEAM CHEMICAL INTEGRATORS, COMPLY STERIGAGE (PER SITE REPORTER).====================== THEY ARE INVESTIGATING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    210301 COMPLY STERIGAGE INDICATOR, PHYSICAL/CHEMICAL STERILIZATION PROCESS JOJ 3M COMPANY * 201809YS

    Patients

    Seq Age Sex Outcome Treatment
    1 *