BEUDAMED
    FDA Adverse Event Summary report: N

    CHEMICAL INDICATOR

    MDR report key: 3197249 · Received June 28, 2013

    Report

    Report Number
    8021896-2013-00002
    Date Received
    June 28, 2013
    Date of Event
    May 29, 2013
    Report Date
    June 28, 2013
    Manufacturer
    ALBERT BROWNE LTD
    Product Code
    JOJ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE UNIT WAS INSPECTED BY A STERIS TECHNICIAN AND WAS FOUND TO BE OPERATING TO SPECIFICATION; NO ISSUES WERE NOTED. THE USER FACILITY DID NOT REPORT ANY FAILED CYCLES. IT WAS CONFIRMED THAT ALL CYCLES PASSED SUCCESSFULLY. A STERIS ACCOUNT MANAGER VISITED THE USER FACILITY AND IDENTIFIED THAT THE FACILITY WAS USING A NON-STERIS CONTAINER. THIS NON-STERIS CONTAINER AND STERIS CI CONFIGURATION HAS NOT BEEN VALIDATED BY STERIS. ON (B)(6) 2013, THE ACCOUNT MANAGER PROVIDED AN IN-SERVICE TO THE USER FACILITY ON THE PROPER USE OF THE V-PRO STERILIZER AND CHEMICAL INDICATORS. NO FURTHER ISSUES HAVE BEEN REPORTED.

    Description of Event or Problem · 1

    CUSTOMER REPORTED CHEMICAL INDICATOR WAS NOT COMPLETELY CHANGING COLOR. AS A RESULT, PROCEDURES WERE DELAYED. INSTRUMENTS WERE REPROCESSED BEFORE USE IN SUBSEQUENT PATIENT PROCEDURES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    295798 CHEMICAL INDICATOR CHEMICAL INDICATOR JOJ ALBERT BROWNE LTD 023599

    Patients

    Seq Age Sex Outcome Treatment
    1 Other