BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    3M STERIGAGE INTEGRATOR

    MDR report key: 12719376 · Received October 28, 2021

    Report

    Report Number
    MW5105012
    Event Type
    Malfunction
    Date Received
    October 28, 2021
    Date of Event
    October 22, 2021
    Report Date
    October 26, 2021
    Manufacturer
    3M COMPANY
    Product Code
    JOJ
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    OK, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    THE 3M INTEGRATOR USED FOR STERILIZATION IS BLEEDING ON TO PEEL PACKS CAUSING COMPROMISED STERILIZATION PACKAGES. FDA SAFETY REPORT ID# (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1614323 3M STERIGAGE INTEGRATOR INDICATOR, PHYSICAL/CHEMICAL STERILIZATION PROCESS JOJ 3M COMPANY DD052023

    Patients

    Seq Age Sex Outcome Treatment
    1