BEUDAMED
    FDA Adverse Event Summary report: N

    VERIFY SIXCESS 270F 4 MINUTE INDICATOR

    MDR report key: 4013399 · Received August 15, 2014

    Report

    Report Number
    8021896-2014-00001
    Date Received
    August 15, 2014
    Date of Event
    July 16, 2014
    Report Date
    August 15, 2014
    Manufacturer
    ALBERT BROWNE LTD
    Product Code
    JOJ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    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

    UPON EXTENSIVE INVESTIGATION BY STERIS AND THE USER FACILITY, STERIS DETERMINED THAT THE INDICATORS HAD BEEN EXPOSED TO EXCESSIVE MOISTURE DURING THE STEAM STERILIZATION PROCESS. STERIS SERVICE AND CLINICAL GROUP PERFORMED AN ASSESSMENT AT THE FACILITY. THE ASSESSMENT SUGGESTED THAT THE CUSTOMER PERFORM MAINTENANCE ON THE STEAM TRAPS AND ADDRESS SOME SYSTEM PROCESSES THAT COULD LEAD TO WET PACKS. ALL INSTRUMENTS IN CYCLES WHERE THE CIS WERE LEAKING WERE REPROCESSED. NO ADDITIONAL ISSUES HAVE BEEN REPORTED AFTER APPROPRIATE CORRECTIVE ACTION WAS TAKEN.

    Description of Event or Problem · 1

    NO INJURIES WERE REPORTED.

    Description of Event or Problem · 1

    THE USER FACILITY REPORTED THAT INK FROM THEIR VERIFY SIXCESS CHEMICAL INDICATORS ARE LEAKING INTO PEEL PACKS. PROCEDURAL DELAYS/CANCELLATIONS HAVE BEEN REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    491306 VERIFY SIXCESS 270F 4 MINUTE INDICATOR CHEMICAL INDICATOR JOJ ALBERT BROWNE LTD 14030

    Patients

    Seq Age Sex Outcome Treatment
    1