BEUDAMED
    FDA Adverse Event Summary report: N

    VERIFY CHEMICAL INDICATOR

    MDR report key: 2506584 · Received March 27, 2012

    Report

    Report Number
    8021896-2012-00002
    Date Received
    March 27, 2012
    Date of Event
    March 6, 2012
    Report Date
    March 27, 2012
    Manufacturer
    ALBERT BROWNE LTD
    Product Code
    JOJ
    PMA / PMN Number
    K102217
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    A STERIS TECHNICIAN WENT ON-SITE AND OBSERVED TWO OPERATORS PLACE THE CHEMICAL INDICATORS IMPROPERLY. SPECIFICALLY, THE OPERATOR DID NOT USE THE ORANGE CLIP SUPPLIED IN THE CI PACKAGING TO AFFIX THE CI INDICATOR FIRMLY INTO PLACE INSIDE THE SYSTEM 1E TRAY. RATHER THE OPERATORS PLACED THE CI LOOSELY INSIDE THE TRAY, CAUSING IT TO FLOAT AND GET STUCK INSIDE THE TRAY WHEN A PROCESSING CYCLE WAS RAN. THE CI CLIPS WERE NOT AVAILABLE WHEN ASKED BY THE STERIS TECHNICIAN. THE TECHNICIAN RAN A PROCESSING CYCLE WHICH COMPLETED SUCCESSFULLY AND THE CI PASSED.THE CI INSTRUCTIONS FOR USE STATE "3. USING THE CLIP PROVIDED, PLACE ONE STRIP IN A SYSTEM 1E PROCESSOR." THE TECHNICIAN PROVIDED IN-SERVICE TRAINING WHEN ON-SITE REGARDING THE PROPER PLACEMENT OF THE CI USING THE CI CLIP.

    Description of Event or Problem · 1

    THE USER FACILITY REPORTED CHEMICAL INDICATOR FAILURES ON CYCLES COMPLETED IN THE SYSTEM 1E PROCESSOR. PATIENT PROCEDURES WERE SUBSEQUENTLY RESCHEDULED AS A RESULT OF THE SCOPES HAVING TO BE REPROCESSED PRIOR TO USE. NO INJURIES WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VERIFY CHEMICAL INDICATOR CHEMICAL INDICATOR JOJ ALBERT BROWNE LTD LCC016 020466

    Patients

    Seq Age Sex Outcome Treatment
    1 30 YR Other