BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PRODUCT NAME 3M COMPLY THERMALOG STEAM CHEMICAL INTEGRATOR

    MDR report key: 16305536 · Received February 3, 2023

    Report

    Report Number
    MW5114711
    Event Type
    Malfunction
    Date Received
    February 3, 2023
    Date of Event
    August 5, 2022
    Report Date
    February 2, 2023
    Manufacturer
    3 M COMPANY
    Product Code
    JOJ
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    OH, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    DESCRIBE EVENT, PROBLEM, OR PRODUCT USE ERROR: 3M STEAM CHEMICAL INTEGRATOR EXPLODES DURING STERILIZATION LEAKING BLUE DYE INTO STERILE PACKAGE/TRAY. THIS HAS BEEN AN ONGOING ISSUE SINCE (B)(6) 2022. HAVE REACHED OUT TO VENDOR, CHANGED LOT NUMBERS AND INTEGRATOR TYPE AND CONTINUE TO HAVE ISSUES. MULTIPLE LOT NUMBERS INVOLVED: 3M COMPLY THERMALOG STEAM CHEMICAL INTEGRATOR 2134- LOTS 202504GC, 202505G, 202508GF; 3M STEAM CHEMICAL INTEGRATOR 1243-LOT FH102025. VENDOR CONTINUES TO POINT FINGER AT HOSPITAL STAFF AND EQUIPMENT ISSUE RATHER THAN PRODUCT ISSUE. I AM HAVING THIS ISSUE AT 4 OF MY HOSPITALS AND HAVE HAD ALL OF MY STEAM STERILIZERS SERVICED AT THE TRAUMA CENTER AND NO ISSUES WERE DISCOVERED. NEED ASSISTANCE WITH RESOLVING THESE ISSUES. STERILE TRAYS/INSTRUMENTS CANNOT BE USED WHEN DYE PACKET EXPLODES CAUSING DELAYS IN SURGERY, UNNECESSARY REPROCESSING EXPENSE AND STAFF TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    114548 PRODUCT NAME 3M COMPLY THERMALOG STEAM CHEMICAL INTEGRATOR INDICATOR, PHYSICAL/CHEMICAL STERILIZATION PROCESS JOJ 3 M COMPANY 2134 202504GC
    114549 PRODUCT NAME 3M COMPLY THERMALOG STEAM CHEMICAL INTEGRATOR INDICATOR, PHYSICAL/CHEMICAL STERILIZATION PROCESS JOJ 3 M COMPANY 2134 202505G
    114550 PRODUCT NAME 3M COMPLY THERMALOG STEAM CHEMICAL INTEGRATOR INDICATOR, PHYSICAL/CHEMICAL STERILIZATION PROCESS JOJ 3 M COMPANY 2134 202508GF
    114551 3M STEAM CHEMICAL INTEGRATOR INDICATOR, PHYSICAL/CHEMICAL STERILIZATION PROCESS JOJ 3 M COMPANY 1243 FH102025

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown