BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONE TRAY PROCESSING KIT TAMPER EVIDENT LOCKS WITH INDICATOR DOTS

    MDR report key: 8582401 · Received May 3, 2019

    Report

    Report Number
    MW5086380
    Event Type
    Malfunction
    Date Received
    May 3, 2019
    Date of Event
    May 1, 2019
    Report Date
    May 1, 2019
    Manufacturer
    INNOVATIVE STERILIZATION TECHNOLOGIES LLC
    Product Code
    KCT
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    PA, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    INNOVATIVE STERILIZATION TECHNOLOGIES, ONE TRAY PROCESSING KIT, ONE OF TWO OF THE "TAMPER EVIDENT LOCKS WITH INDICATOR DOTS", DID NOT TRANSITION TO "BLACK" FOLLOWING PROCESSING. THE INTERNAL "INTEGRATOR" HAD FULLY TRANSITIONED, AND THE "BIOLOGICAL" TEST WAS NEGATIVE. FDA SAFETY REPORT ID# (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    373601 ONE TRAY PROCESSING KIT TAMPER EVIDENT LOCKS WITH INDICATOR DOTS WRAP CONTAINERS, TRAYS, CASSETTES AND OTHER ACCESSORIES KCT INNOVATIVE STERILIZATION TECHNOLOGIES LLC OTK-210 K03180884

    Patients

    Seq Age Sex Outcome Treatment
    1