BEUDAMED
    FDA Adverse Event Summary report: N

    VERIFY BIOLOGICAL/INTEGRATOR CHALLENGE PACK

    MDR report key: 2222143 · Received August 24, 2011

    Report

    Report Number
    3004080920-2011-00003
    Date Received
    August 24, 2011
    Date of Event
    June 17, 2011
    Report Date
    August 24, 2011
    Manufacturer
    STERIS BIOLOGICAL OPERATIONS
    Product Code
    FRC
    PMA / PMN Number
    K854902
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A STERIS TECHNICIAN INSPECTED THE STERILIZER SUBJECT OF THIS EVENT AND FOUND THE EQUIPMENT TO BE OPERATING PROPERLY; NO ISSUES WERE IDENTIFIED. THE USER FACILITY REPORTED THAT THE CYCLE COMPLETED SUCCESSFULLY, ALL PROCESSING PARAMETERS WERE MET AND BOTH THE CHEMICAL INDICATOR AND CONTROL BIOLOGICAL INDICATOR PASSED. THE USER FACILITY RETURNED THE INVALID BIOLOGICAL INDICATOR FOR TESTING. THE RESULTS OF THE TESTING IDENTIFIED THAT THE CAP OF THE BIOLOGICAL INDICATOR WAS NOT FULLY DEPRESSED FOLLOWING THE STERILIZATION CYCLE, WHICH RESULTED IN THE BIOLOGICAL INDICATOR MEDIA EVAPORATING WHEN INCUBATED AND CAUSED THE INVALID TEST RESULT. RETENTION TESTING COMPLETED ON THE LOT OF BIOLOGICAL INDICATORS USED BY THE USER FACILITY SHOWED NO ABNORMALITIES; ALL INDICATORS MET SPECIFICATIONS AND PASSED TESTING. INSTRUCTIONS FOR USE FOR THIS PRODUCT DIRECT CUSTOMERS IN SECTION 9.3 THAT "THE INDICATOR IS PROPERLY SEALED WHEN THE CAP IS PUSHED DOWN TO THE SECOND BLACK BAR ON THE VIAL LABEL." THE CAUSE OF THIS EVENT IS OPERATOR ERROR AS THE USER DID NOT PROPERLY DEPRESS THE BIOLOGICAL INDICATOR CAP. IN-SERVICE TRAINING ON PROPER PREPARATION, PLACEMENT, ACTIVATION AND INCUBATION OF THE BIOLOGICAL INDICATOR WAS PERFORMED ON (B)(6) 2011. IT IS NOTED THAT (B)(4) STANDARDS AND THE BIOLOGICAL INDICATOR INSTRUCTIONS FOR USE STATE THAT USE OF A BIOLOGICAL/INTEGRATOR CHALLENGE PACK IS NOT REQUIRED TO BE PLACED, INCUBATED, AND EVALUATED IF NO IMPLANTABLE DEVICES ARE INCLUDED IN A LOAD. THE INSTRUMENTS PROCESSED IN THIS LOAD WERE ACCEPTABLE FOR RELEASE BECAUSE: THE STERILIZATION CYCLE COMPLETED SUCCESSFULLY; THE USER FACILITY REPORTED THAT THE CHEMICAL INDICATOR AND CONTROL BIOLOGICAL INDICTOR PASSED; AND THE PROCESSED INSTRUMENTS CONTAINED NO IMPLANTABLE DEVICES.

    Description of Event or Problem · 1

    THE USER FACILITY REPORTED THAT THEY RECEIVED AN INVALID BIOLOGICAL INDICATOR RESULT FOLLOWING A STEAM STERILIZATION PROCESSING CYCLE. AN INVALID RESULT MEANS THE INDICATOR WAS NEITHER POSITIVE NOR NEGATIVE. THE INSTRUMENTS PRESENT IN THE PROCESSING CYCLE WERE SUBSEQUENTLY USED IN PATIENT PROCEDURES; NO IMPLANTABLE DEVICES WERE PRESENT IN THE CYCLE. THE USER FACILITY REPORTED THAT NO ACTIONS WERE TAKEN BY THE HOSPITAL FOLLOWING THE INVALID TEST RESULT. NO INJURIES HAVE BEEN REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VERIFY BIOLOGICAL/INTEGRATOR CHALLENGE PACK BIOLOGICAL INDICATOR FRC STERIS BIOLOGICAL OPERATIONS 111111

    Patients

    Seq Age Sex Outcome Treatment
    1