BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STERILIZATION PEEL POUCH

    MDR report key: 21549621 · Received March 7, 2025

    Report

    Report Number
    MW5167404
    Event Type
    Injury
    Date Received
    March 7, 2025
    Date of Event
    February 20, 2025
    Report Date
    March 3, 2025
    Manufacturer
    MICROCARE MEDICAL
    Product Code
    KCT
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    AK, US
    Reporter Occupation
    RISK MANAGER
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    THROUGHOUT THE CONSORTIUM, WE HAVE IDENTIFIED A TREND OF SELF-SEAL STERILIZATION POUCHES EXHIBITING COMPROMISED GLUE SEALS. THE POUCHES HAVE BEEN FOUND TO DISPLAY A SMALL PUCKER/WRINKLE, SUGGESTING INCOMPLETE CLOSURE. THE INTEGRITY OF THE SEAL WAS CHECKED BY REMOVING THE INSTRUMENT AND PUTTING WATER IN THE PACKAGE. LEAKAGE WAS FOUND ACROSS THE BOTTOM OF THE PACK WHERE IT IS MANUALLY SEALED DURING PROCESSING, CONFIRMING THE PACKAGE INTEGRITY HAD BEEN COMPROMISED. THIS ISSUE HAS BEEN OBSERVED ACROSS MULTIPLE BRANDS, STERILIZERS, AND SITES, RULING OUT SINGLE-SOURCE VARIABILITY. REF REPORT: MW5167405.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2144205 STERILIZATION PEEL POUCH STERILIZATION WRAP CONTAINERS, TRAYS, CASSETTES & OTHER ACCESSORIES KCT MICROCARE MEDICAL

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention