BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONE TRAY

    MDR report key: 6590316 · Received May 25, 2017

    Report

    Report Number
    6590316
    Event Type
    Malfunction
    Date Received
    May 25, 2017
    Date of Event
    April 26, 2017
    Report Date
    May 8, 2017
    Manufacturer
    INNOVATIVE STERILIZATION TECHNOLOGIES LLC
    Product Code
    KCT
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS DEVICE IS AVAILABLE FOR RETURN. A FOLLOW UP MDR WILL BE SUBMITTED UPON COMPLETION OF THE DEVICE INVESTIGATION.

    Description of Event or Problem · 1

    WE HAVE RECENTLY OBTAINED ONE TRAY TO USE IN OUR IMMEDIATE USE STEAM STERILIZER. THIS IS USED TO GET QUICKER ACCESS TO INSTRUMENTS NEEDED WITH THE PREFACE THAT THIS "ONE TRAY" WOULD PROVIDE THE RAPID STERILIZATION TO TERMINALLY STERILIZE WITH IN THE REGULATORY GUIDELINES IN A PRE-VACUUM CYCLE IN 4 MINUTES. THIS IS COMPLETED BY A FILTERED VENT AND THE THERMODYNAMIC BEHAVIOR OF STEAM. THESE FILTERS ARE LABELED AS HYDROPHOBIC- MEANING WATER IS TO BEAD ON THEM AND NOT GO THROUGH THEM. THESE FILTERS ARE A ONE TIME USE AND ARE CHANGED WITH EACH PROCESS. IT WAS OUR EXPERIENCE THAT THE FILTERS HAD NOT BEEN HYDROPHOBIC. THERE WAS APPARENT WATER AT THE BOTTOM OF THE TRAY. MANUFACTURER RESPONSE FOR SEALED STERILIZATION CONTAINER, ONE TRAY (PER SITE REPORTER): THE REPRESENTATIVE CAME TO THE O.R. AND WATCH A CYCLE RUN. EVERYTHING THAT STAFF DID WAS APPROPRIATE AND TO THE MANUFACTURER'S RECOMMENDATIONS. THEY HAD SUGGESTED THAT THIS WAS POSSIBLE DUE TO OUR WATER QUALITY. THE SAME TESTING WAS COMPLETED WITH STERILE WATER AND IT RESULTED IN THE SAME DEFECT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    371060 ONE TRAY STERILIZATION WRAP CONTAINERS, TRAYS, CASSETTES & OTHER ACCESSORIES KCT INNOVATIVE STERILIZATION TECHNOLOGIES LLC 85280, 84997, 85289, 85894

    Patients

    Seq Age Sex Outcome Treatment
    1