BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONE TRAY

    MDR report key: 8678224 · Received June 7, 2019

    Report

    Report Number
    8678224
    Event Type
    Malfunction
    Date Received
    June 7, 2019
    Date of Event
    February 13, 2019
    Report Date
    March 26, 2019
    Manufacturer
    INNOVATIVE STERILIZATION TECHNOLOGIES LLC
    Product Code
    KCT
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MO
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    THE OPERATING ROOM DEPARTMENT HAS BEEN EXPERIENCING ISSUES INVOLVING THE ONE TRAYS. THE TRAYS HAVE BEEN FLAKING OFF AND DIVOTS FROM THE SILICONE SEAL AROUND THE BRACKET WHICH HOLDS THE FILTER IN PLACE DURING THE STERILIZATION PROCESS. THERE IS ALSO NOTED RUST STARTING TO APPEAR ON THE BOTTOM OF THE TRAYS PRIOR TO USE. THESE TRAYS ARE NEWLY PURCHASED AND HAVE NEVER BEEN USED. THE OPERATING ROOM TEAM OPENED AN ENTIRE CONTAINER OF THE ONE TRAYS AND NOTED ALL OF THEM WERE COMPROMISED WITH RUST AND/OR FAILURE OF THE SILICONE SEAL. WE HAVE HAD A WATER-SOLUBLE TEST COMPLETED WITH RESULTS PENDING. THE MANUFACTURER IS UNSURE WHAT IS CAUSING THE DISCOLORATION. OUR OPERATING ROOM TEAM DID PROVIDE ONE OF THESE TRAYS TO A LOCAL REP WITH NO INFORMATION AS TO THEIR INTERNAL EVALUATION. THE REP DID BRING A NEW TRAY, BUT IT ALSO SHOWED SIGNS OF DISCOLORATION. NO PATIENTS HAVE BEEN HARMED FROM THESE TRAYS/INCIDENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    471105 ONE TRAY STERILIZATION WRAP CONTAINERS, TRAYS, CASSETTES & OTHER ACCESSORIES KCT INNOVATIVE STERILIZATION TECHNOLOGIES LLC

    Patients

    Seq Age Sex Outcome Treatment
    1