BEUDAMED
    FDA Adverse Event Summary report: N

    VERIFY V24 SELF CONTAINED BI

    MDR report key: 3081050 · Received April 26, 2013

    Report

    Report Number
    3004080920-2013-00003
    Date Received
    April 26, 2013
    Date of Event
    March 25, 2013
    Report Date
    April 26, 2013
    Manufacturer
    STERIS BIOLOGICAL OPERATIONS
    Product Code
    FRC
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WY, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A STERIS SERVICE TECHNICIAN INSPECTED THE V-PRO STERILIZER AND CONFIRMED THAT THE UNIT WAS OPERATING PROPERLY. THE STERILIZER HAS REMAINED IN SERVICE WITH NO FURTHER ISSUES. IN ADDITION, THE FACILITY MONITORS ALL V-PRO CYCLES WITH CHEMICAL INDICATORS (CI); THE CI USED IN THE CYCLE WAS REPORTED TO HAVE PASSED. THE PASSING CI DEMONSTRATES THAT THE LOAD HAS BEEN PROCESSED/EXPOSED TO VAPORIZED HYDROGEN PEROXIDE. RETAIN TESTING COMPLETED ON THE LOT SUBJECT OF THE REPORTED EVENT EVIDENCED PASSING RESULTS, NO ISSUES WERE NOTED WITH THE BIOLOGICAL INDICATORS. THE DHR ALSO EVIDENCES THE LOT WAS MANUFACTURED TO SPECIFICATION. THE RESULTS OF THE STERILIZER RECORD, CI, AND EQUIPMENT INSPECTION DEMONSTRATE THAT THE INSTRUMENTS PROCESSED IN THE UNIT WERE PROPERLY STERILIZED. THE USER FACILITY STATED THAT THE CAP ON THE BIOLOGICAL INDICATOR VIAL WAS PRESSED DOWN BEFORE BEING PLACED IN THE V-PRO STERILIZER. THE INSTRUCTIONS FOR USE STATES, "BEFORE USE EXAMINE BIOLOGICAL INDICATOR VIAL TO ENSURE CAP BOTTOM DOES NOT EXTEND BEYOND TOP ARROW ON VIAL LABEL AND CAP FREELY ROTATES". STERIS OFFERED IN-SERVICE TRAINING ON THE PROPER USE AND HANDLING OF THE BI AND IS WORKING WITH THE FACILITY TO SCHEDULE A DATE.

    Description of Event or Problem · 1

    THE USER FACILITY REPORTED THAT INSTRUMENTS PROCESSED IN A V-PRO STERILIZER CYCLE WERE USED IN PATIENT PROCEDURES AS THE CYCLE PARAMETERS WERE MET AND THE CHEMICAL INDICATOR PASSED. THE USER FACILITY LATER DETERMINED THAT THE BIOLOGICAL INDICATOR (BI) USED IN THE CYCLE WAS POSITIVE FOR GROWTH. THE PHYSICIANS WHO USED THE INSTRUMENTS IN THE LOAD WERE NOTIFIED AND IT IS REPORTED THAT THEY ARE MONITORING THEIR PATIENTS. NO INJURIES OR PROCEDURE DELAYS HAVE BEEN REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    180899 VERIFY V24 SELF CONTAINED BI BIOLOGICAL INDICATOR FRC STERIS BIOLOGICAL OPERATIONS 130901A

    Patients

    Seq Age Sex Outcome Treatment
    1 Other