BEUDAMED
    FDA Adverse Event Summary report: N

    VERFIY SIXCESS 270F 4 MINUTE INDICATOR

    MDR report key: 3178303 · Received June 19, 2013

    Report

    Report Number
    8021896-2013-00001
    Date Received
    June 19, 2013
    Report Date
    June 19, 2013
    Manufacturer
    ALBERT BROWNE LTD
    Product Code
    JOJ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE USER FACILITY REPORTED THAT FOLLOWING A PERIOD OF STORAGE AFTER PROCESSING, CHEMICAL INDICATORS INSIDE OF STERILIZED POUCHES RETURNED TO THEIR ORIGINAL COLOR PRIOR TO PROCESSING WHICH REQUIRED THE FACILITY TO REPROCESS THE POUCHED DEVICES. NO INJURIES OR PROCEDURAL DELAYS/CANCELLATIONS HAVE BEEN REPORTED. A STERIS SERVICE TECHNICIAN AND SALES REPRESENTATIVE INTERVIEWED THE USER FACILITY SPD MANAGER AND DETERMINED THAT THE USER FACILITY STORES STERILIZED DEVICES IN POUCHES WITH THE CHEMICAL INDICATOR FOR A PERIOD LONGER THAN 6 MONTHS PRIOR TO USE. PHOTOS TAKEN OF THE INDICATORS SHOWED THAT THE INDICATORS MAY HAVE BEEN PLACED IN "WET LOADS" AS THE INDICATORS APPEARED TO HAVE BEEN IN WATER. THE INSTRUCTIONS FOR USE INDICATOR STATE: "STORE UNPROCESSED INDICATORS AT 32 - 86 F AND 30% - 60% RELATIVE HUMIDITY. STORE UNPROCESSED AND PROCESSED INDICATORS OUT OF DIRECT LIGHT. DO NOT STORE THE INDICATORS NEAR STEAM STERILIZER OR NEAR STRONG ALKALINE OR ACIDIC PRODUCTS. THESE STORAGE CONDITIONS SHOULD BE MAINTAINED AFTER USE WHEN THE INDICATOR IS FILED. THE ENDPOINT COLOR (BLUE/PURPLE) OF THE INDICATOR WILL REMAIN STABLE FOR NOT LESS THAN 6 MONTHS FROM THE DATE OF PROCESSING". RETAIN TESTING CONDUCTED ON THE INDICATOR LOT NUMBERS IDENTIFIED AT THE USER FACILITY CONFIRMED THAT THE LOTS WERE MANUFACTURED TO SPECIFICATION; NO ISSUES WERE NOTED. THE STERIS TECHNICIAN STATED THAT THE USER FACILITY IS NO LONGER USING VERIFY SIXCESS 270F 4 MINUTE INDICATOR. MULTIPLE ATTEMPTS HAVE BEEN MADE TO OBTAIN ADDITIONAL EVENT INFORMATION, HOWEVER, THE USER FACILITY WILL NOT RESPOND.

    Description of Event or Problem · 1

    (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    277669 VERFIY SIXCESS 270F 4 MINUTE INDICATOR CHEMICAL INDICATOR JOJ ALBERT BROWNE LTD

    Patients

    Seq Age Sex Outcome Treatment
    1 Other