BEUDAMED
    FDA Adverse Event Summary report: N

    VERIFY VAPORIZED VH202 PROCESS INDICATOR

    MDR report key: 4266693 · Received November 20, 2014

    Report

    Report Number
    8021896-2014-00004
    Date Received
    November 20, 2014
    Date of Event
    October 22, 2014
    Report Date
    November 20, 2014
    Manufacturer
    ALBERT BROWNE LTD
    Product Code
    JOJ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A STERIS SERVICE TECHNICIAN INSPECTED THE V-PRO MAX STERILIZER IN WHICH THE PROCESS INDICATOR WAS PLACED IN AND FOUND THE UNIT TO BE OPERATING PROPERLY; NO ISSUES WERE NOTED. USER FACILITY PERSONNEL WERE NOT STORING THE PROCESS INDICATOR PROPERLY AS STATED IN THE INSTRUCTIONS FOR USE, SPECIFICALLY, STORING THE INDICATORS IN DIRECT LIGHT. INSTRUCTIONS FOR USE: STORAGE CONDITIONS- STORE ALL UNUSED VERIFY VAPORIZED PROCESS INDICATORS AT 6-30 CELSIUS, 30-60% RELATIVE HUMIDITY AWAY FROM DIRECT LIGHT. DO NOT STORE INDICATORS NEAR HEAT, MOISTURE, OXIDIZING AGENTS, ACIDS/ALKALIS OR CLEANING/DISINFECTING AGENTS. THESE STORAGE CONDITIONS SHOULD BE MAINTAINED AFTER USE E.G. WHEN THE INDICATOR IS FILED. THE USER FACILITY COUNSELED STAFF ON THE PROPER USE AND HANDLING OF THE PROCESS INDICATORS. THE USER FACILITY DECLINED ADDITIONAL IN-SERVICE TRAINING FROM STERIS. RETAIN TESTING AND DHR REVIEW COULD NOT BE CONDUCTED AS THE LOT NUMBER OF THE PROCESS INDICATORS COULD NOT BE OBTAINED. THE USER FACILITY STATED THAT THE LOT OF PROCESS INDICATORS WAS DISPOSED OF.

    Description of Event or Problem · 1

    THE USER FACILITY REPORTED THAT THEIR PROCESS INDICATOR DID NOT EVIDENCE PASSING RESULTS. THE PROCESS INDICATOR WAS PLACED IN AN EMPTY LOAD HOWEVER, A PROCEDURE CANCELLATION WAS REPORTED AS ITEMS REQUIRED PROCESSING AT ANOTHER FACILITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    752394 VERIFY VAPORIZED VH202 PROCESS INDICATOR CHEMICAL INDICATOR JOJ ALBERT BROWNE LTD

    Patients

    Seq Age Sex Outcome Treatment
    1 Other