BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VERIFY ASSERT STEAM PROCESS CHALLENGE DEVICE

    MDR report key: 15335443 · Received September 1, 2022

    Report

    Report Number
    3004080920-2022-00005
    Event Type
    Malfunction
    Date Received
    September 1, 2022
    Date of Event
    July 19, 2022
    Report Date
    September 1, 2022
    Manufacturer
    STERIS CORPORATION
    Product Code
    OWP
    UDI-DI
    10724995153035
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    NO PROCEDURE DELAYS HAVE BEEN REPORTED. RETAIN TESTING WAS PERFORMED ON THE LOT NUMBER SUBJECT OF THE REPORTED EVENT; NO ISSUES WERE NOTED. THE DHR FOR THE SUBJECT LOT WAS REVIEWED AND NO ABNORMALITIES WERE FOUND. THE PROCESS CHALLENGE DEVICE INSTRUCTIONS FOR USE (PG. 1) STATES, "INSTRUCTIONS FOR USE: BEFORE USE, EXAMINE THE PCD TO ENSURE THAT THE FOIL AND SEAL ARE INTACT. EXAMINE THE INTEGRATOR THROUGH THE PLASTIC, TO ENSURE THE PCD HAS NOT BEEN USED PREVIOUSLY." NO ADDITIONAL ISSUES HAVE BEEN REPORTED.

    Description of Event or Problem · 0

    THE USER FACILITY REPORTED VIA MEDWATCH (MW5111090) THAT THEY RECEIVED "DRIED UP" CONTROL CONTAINERS AND THAT THEIR BIOLOGICAL TESTS HAVE BEEN FOUND DRY PRIOR TO AND AFTER PROCESSING. NO REPORT OF INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2595236 VERIFY ASSERT STEAM PROCESS CHALLENGE DEVICE VERIFY ASSERT STEAM PROCESS CHALLENGE DEVICE OWP STERIS CORPORATION LCB033 20230823 10724995153035

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown