BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    3M COMPLY TAPE

    MDR report key: 24650230 · Received March 20, 2026

    Report

    Report Number
    MW5185492
    Event Type
    Malfunction
    Date Received
    March 20, 2026
    Date of Event
    March 10, 2026
    Report Date
    March 12, 2026
    Manufacturer
    3M COMPANY/ SOLVENTUM US LLC.
    Product Code
    JOJ
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    IN, US
    Reporter Occupation
    RISK MANAGER
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    3M COMPLY TAPE REF: 1322-18MM LOT: 251106 EXP: 05-06-2027 THIS WEEK ON OUR PAR. THIS IS THE TAPE WE USE TO WRAP OUR INSTRUMENT SETS. ENTIRE LOAD PLACED IN STERILIZER AND PROCESSED. THE STERILIZER RAN ITS ENTIRE CYCLE WITH NO ERRORS, BUT WHEN WE PULLED OUT THE LOAD NONE OF THE TAPE HAD CHANGED TO THE STRIPES TO INDICATE IT HAD BEEN RUN THROUGH THE STEAM CYCLE. LOAD QUARANTINED. RAN ADDITIONAL LOADS USING THE NEW ROLL OF TAPE. SAME RESULT. TAPE DID NOT TURN TO STRIPES. RAN ADDITIONAL LOADS WITH A TAPE FROM A DIFFERENT LOT NUMBER. WORKED AS EXPECTED. STRIPES PRESENT AFTER PROCESSING. PT CODE: 4582. DEVICE CODES: 2910, 3270, 2588. REF: MW5185493.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    717452 3M COMPLY TAPE INDICATOR, PHYSICAL/CHEMICAL STERILIZATION PROCESS JOJ 3M COMPANY/ SOLVENTUM US LLC. 1322-18MM 251106

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown