BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    3M COMPLY STERIGAGE

    MDR report key: 2841557 · Received October 12, 2012

    Report

    Report Number
    2841557
    Event Type
    Malfunction
    Date Received
    October 12, 2012
    Date of Event
    October 4, 2012
    Report Date
    October 12, 2012
    Manufacturer
    3M HEALTH CARE BUSINESS
    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

    3M CLASS 5 EMULATING INTEGRATOR (1243) BURST INSIDE OF A SURGICAL INSTRUMENT TRAY AND CONTAMINATED THE INSTRUMENTS. THE INSTRUMENT TRAY HAD TO BE REPROCESSED IN STERILE PROCESSING IN ORDER FOR THE SURGICAL CASE TO PROCEED.======================MANUFACTURER RESPONSE FOR STERILIZATION INTEGRATOR, 3M COMPLY STERIGAGE CLASS STEAM CHEMICAL INTEGRATOR (PER SITE REPORTER).======================3M SENT US A LETTER THAT A CORRECTIVE ACTION PROJECT WAS PUT IN PLACE TO IDENTIFY DESIGN OR MANUFACT. IMPROVEMENTS THAT COULD REDUCE THE OCCURRENCE OF LEAKING INTEGRATORS...MANUFACTURING CHANGES HAVE BEEN MADE...PREVENTIVE MAINTENANCE SCHEDULES AND SPECS HAVE BEEN TIGHTENED TO ENSURE GOOD ADHESION OF THE GRAPHICS TO THE FOIL AND CORRECT VALVE-HOLE PLACEMENT...WILL CONTINUE TO MONITOR COMPLAINTS..AND IMPLEMENT FURTHER IMPROVEMENTS IF NECESSARY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 3M COMPLY STERIGAGE STERILIZATION INTEGRATOR JOJ 3M HEALTH CARE BUSINESS 1243 201705YG

    Patients

    Seq Age Sex Outcome Treatment
    1 *