BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    3M ATTEST STEAM CHEMICAL INTEGRATOR WITH EXTENDER

    MDR report key: 24709562 · Received March 30, 2026

    Report

    Report Number
    MW5186046
    Event Type
    Malfunction
    Date Received
    March 30, 2026
    Date of Event
    March 3, 2026
    Report Date
    March 24, 2026
    Manufacturer
    3M/SOLVENTUM US LLC
    Product Code
    JOJ
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Occupation
    RISK MANAGER
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    AFTER STEAM STERILIZATION LOAD COMPLETED, SPD TECH HAD IDENTIFIED MULTIPLE INSTRUMENTS IN PEEL POUCHES THAT HAD A CHEMICAL INTEGRATOR (CI) WITH INK LEAKING FROM WITHIN. SPD MANAGER RULED OUT STERILIZER EQUIPMENT FAILURE BY VERIFYING THAT THE PEEL PACKS WITH DAMAGED CI'S WERE RUN IN DIFFERENT AUTOCLAVES AND CYCLES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    770152 3M ATTEST STEAM CHEMICAL INTEGRATOR WITH EXTENDER INDICATOR, PHYSICAL/CHEMICAL STERILIZATION PROCESS JOJ 3M/SOLVENTUM US LLC 1243RE SY012029

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown