BEUDAMED
    FDA Adverse Event Summary report: N

    VERIFY SIXCESS 270F 4 MINUTE INDICATOR

    MDR report key: 2617974 · Received June 15, 2012

    Report

    Report Number
    8021896-2012-00004
    Date Received
    June 15, 2012
    Date of Event
    May 10, 2012
    Report Date
    June 15, 2012
    Manufacturer
    ALBERT BROWNE LTD
    Product Code
    JOJ
    PMA / PMN Number
    K070461
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    STERIS HAS SCHEDULED IN-SERVICE TRAINING ON PROPER USE AND HANDLING OF THE INDICATORS FOR (B)(4), 2012.

    Additional Manufacturer Narrative · 1

    THE USER FACILITY REPORTED THE VERIFY INTEGRATOR INK DOT HAD A BUBBLE ON IT AFTER BEING STERILIZED, AND THE INK DOT HAD 'ESCAPED', CAUSING IT TO BE INTERPRETED AS AN INCONCLUSIVE RESULT. THE INSTRUMENTS WERE REPROCESSED PRIOR TO USE IN PATIENT PROCEDURES. NO INJURIES, PROCEDURAL CANCELLATIONS OR DELAYS REPORTED. STERIS DISPATCHED A SERVICE TECHNICIAN ON-SITE; THE USER FACILITY WAS UNABLE TO PROVIDE THE TECHNICIAN WITH THE CYCLE PRINTOUT OF THE INCONCLUSIVE RESULT CYCLE. THE USER FACILITY WAS UNABLE TO REPORT WHICH STERILIZER WAS SUBJECT OF THE REPORTED EVENT. THE CUSTOMER REPORTED THE EVENT COULD BE ATTRIBUTED TO MISUSE/MISHANDLING. THE TECHNICIAN INSPECTED BOTH STERILIZERS IN USE IN THE STERILE PROCESSING DEPARTMENT AND FOUND BOTH UNITS WERE OPERATING PROPERLY; NO ISSUES NOTED. ALL SUBSEQUENT LOADS RUN AFTER THE REPORTED EVENT COMPLETED SUCCESSFULLY AND NO ISSUES WERE NOTED. PICTURES TAKEN BY THE TECHNICIAN OF THE INDICATOR EVIDENCE THE INDICATOR APPEARED TO HAVE CHANGED COLOR BUT BECAUSE OF A 'WET LOAD' OR BEING PLACED IN A PUDDLE OF WATER IN THE STERILIZER, THE LAMINATE WAS RAISED MAKING THE RESULT APPEAR INCONCLUSIVE. RETENTION TESTING WAS COMPLETED AND EVIDENCED PASSING RESULTS. THE DHR EVIDENCES THE LOT WAS MANUFACTURED TO SPECIFICATION. STERIS WILL REQUEST A CLINICIAN GO ON-SITE TO REVIEW THE FACILITY'S PRACTICES FOR HANDLING AND PROCESSING INDICATORS.

    Description of Event or Problem · 1

    (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VERIFY SIXCESS 270F 4 MINUTE INDICATOR CHEMICAL INDICATOR JOJ ALBERT BROWNE LTD 021856

    Patients

    Seq Age Sex Outcome Treatment
    1 30 YR Other