BEUDAMED
    FDA Adverse Event Summary report: N

    VERIFY VAPORIZED VH202 PROCESS INDICATOR

    MDR report key: 4031478 · Received August 22, 2014

    Report

    Report Number
    8021896-2014-00002
    Date Received
    August 22, 2014
    Date of Event
    July 23, 2014
    Report Date
    August 22, 2014
    Manufacturer
    ALBERT BROWNE LTD
    Product Code
    JOJ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION OF THIS EVENT IS CURRENTLY IN PROCESS. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Additional Manufacturer Narrative · 1

    THE USER FACILITY REPORTED TWO PROCESSED CHEMICAL INDICATORS WERE INTERPRETED AS HAVING FAILED RESULTS. STERIS QUALITY RECEIVED PICTURES OF THE INDICATORS AND CONFIRMED THE CUSTOMER CORRECTLY INTERPRETED THE INDICATOR RESULT AS FAILED AND REPROCESSED THE INSTRUMENT PRESENT IN A V-PRO MAX UNIT. RETAIN TESTING CONDUCTED ON THE INDICATOR LOTS SUBJECT OF THE EVENT CONFIRMED THAT THE LOTS WERE MANUFACTURED TO SPECIFICATION; NO ISSUES WERE NOTED. UNUSED SAMPLES OF THE AFFECTED LOTS WERE REQUESTED FROM THE USER FACILITY HOWEVER NO SAMPLES WERE RECEIVED. THE USER FACILITY PROCESSES THE VERIFY INTEGRATING INDICATORS IN A STERIS V-PRO MAX STERILIZER. THE CYCLES SUBJECT OF THE REPORTED EVENT PASSED WITHOUT ALARMS OR ABORTS. STERIS SERVICE VERIFIED THE V-PRO MAX IS OPERATING TO SPECIFICATION FOLLOWING THE EVENT. THE STERIS ACCOUNT MANAGER CONTACTED THE FACILITY FOLLOWING THE EVENT AND CONFIRMED NO FURTHER ISSUES HAVE BEEN REPORTED.

    Description of Event or Problem · 1

    THE USER FACILITY REPORTED TWO CHEMICAL INDICATORS WERE INTERPRETED AS HAVING FAILED RESULTS. THE INSTRUMENT INCLUDED IN THE CYCLE WAS REPROCESSED BEFORE USE IN A PATIENT PROCEDURE. A PROCEDURAL DELAY WAS REPORTED DUE TO THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    509149 VERIFY VAPORIZED VH202 PROCESS INDICATOR CHEMICAL INDICATOR JOJ ALBERT BROWNE LTD 024919

    Patients

    Seq Age Sex Outcome Treatment
    1 Other