BEUDAMED
    FDA Adverse Event Summary report: N

    VERIFY SIXCESS FLASH CHEMICAL INDICATOR

    MDR report key: 6059438 · Received October 26, 2016

    Report

    Report Number
    8021896-2016-00003
    Date Received
    October 26, 2016
    Date of Event
    September 26, 2016
    Report Date
    October 26, 2016
    Manufacturer
    ALBERT BROWNE LTD
    Product Code
    JOJ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    NO INJURY, PROCEDURE DELAYS, OR CANCELLATION OCCURRED AS A RESULT OF THE REPORTED EVENT. THE USER FACILITY STATED THAT A THIRD PARTY BIOLOGICAL INDICATOR ALSO DID NOT EVIDENCE PASSING RESULTS FOLLOWING THE STERILIZATION CYCLE. A STERIS SERVICE TECHNICIAN ARRIVED ON-SITE AND IDENTIFIED THE REPORTED EVENT OCCURRED IN A STERIS 20" CENTURY STERILIZER. A REVIEW OF THE CYCLE PRINT OUT CONFIRMED THE CYCLE TO HAVE PROPERLY PASSED. THE TECHNICIAN TESTED THE STERILIZER AND CONFIRMED THE UNIT TO BE OPERATING ACCORDING TO SPECIFICATION. THE VERIFY SIXCESS FLASH CHEMICAL INDICATOR'S INSTRUCTIONS FOR USE STATE "IF THE INDICATOR IS NOT A BLUE/PURPLE COLOR, CRITICAL STERILIZATION PARAMETERS WERE NOT MET AND THE FLASH STERILIZED ITEM(S) SHOULD NOT BE USED. FOLLOW DEPARTMENT PROCEDURES FOR REPORTING STERILIZATION FAILURES." RETAIN TESTING ON THE LOT NUMBER OF THE VERIFY SIXCESS FLASH CHEMICAL INDICATOR SUBJECT OF THE EVENT WAS PERFORMED AND NO ISSUES WERE NOTED. NO ADDITIONAL ISSUES HAVE BEEN REPORTED WITH THE STERILIZER OR WITH THE VERIFY SIXCESS FLASH CHEMICAL INDICATORS. STERIS WILL OFFER IN-SERVICE TRAINING TO THE USER FACILITY REGARDING THE PROPER USE AND OPERATION OF THE VERIFY SIXCESS FLASH CHEMICAL INDICATORS.

    Description of Event or Problem · 1

    THE USER FACILITY REPORTED THAT A VERIFY SIXCESS FLASH CHEMICAL INDICATOR DID NOT EVIDENCE PASSING RESULTS FOLLOWING A STERILIZATION CYCLE. THE INSTRUMENTS WERE SUBSEQUENTLY USED IN A PATIENT PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    709562 VERIFY SIXCESS FLASH CHEMICAL INDICATOR CHEMICAL INDICATOR JOJ ALBERT BROWNE LTD 028328

    Patients

    Seq Age Sex Outcome Treatment
    1 Other