BEUDAMED
    FDA Adverse Event Summary report: N

    VERIFY V24 SELF CONTAINED BI

    MDR report key: 3083167 · Received April 29, 2013

    Report

    Report Number
    3004080920-2013-00004
    Date Received
    April 29, 2013
    Date of Event
    April 5, 2013
    Report Date
    April 29, 2013
    Manufacturer
    STERIS MEXICO, S. DE R.L. DE C.V.
    Product Code
    FRC
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    RETAIN TESTING COMPLETED ON LOT #130801A, SUBJECT OF THE REPORTED EVENT, EVIDENCED PASSING RESULTS (NEGATIVE GROWTH). THE DEVICE HISTORY RECORD WAS ALSO REVIEWED AND DOCUMENTS THAT THE LOT WAS MANUFACTURED TO SPECIFICATION, WITH NO ANOMALIES NOTED. IN ADDITION, THE FACILITY MONITORS V-PRO CYCLES WITH CHEMICAL INDICATORS (CI); THE CI USED IN THE CYCLE WAS REPORTED TO HAVE PASSED. THE PASSING CI RESULTS DEMONSTRATE THAT THE LOAD HAS BEEN EXPOSED TO THE REQUIRED CONCENTRATION OF VAPORIZED HYDROGEN PEROXIDE. A STERIS ACCOUNT MANAGER AND CLINICAL EDUCATION SPECIALIST ARRIVED AT THE FACILITY ON (B)(4), 2013 TO REVIEW THE HOSPITAL'S PROCEDURAL PRACTICES IN HANDLING SCBIS. DURING THEIR VISIT, THE ACCOUNT MANAGER OBSERVED ONE FACILITY PERSONNEL MANUALLY "CAPPING" AND "CRUSHING" THE SCBI. INSTRUCTIONS FOR USE STATES, "TO SEAL AND ACTIVATE, PLACE THE SCBI INTO THE SPECIALLY DESIGNED CAVITY OF THE SCBI HP ACTIVATOR". THE INSTRUCTIONS FOR USE FURTHER STATES, "CAUTION: ALWAYS USE THE ACTIVATOR TO CRUSH THE MEDIA AMPOULE AS INCORRECT ACTIVATION MAY LEAD TO USER INJURY". THE ACCOUNT MANAGER AND CLINICAL EDUCATION SPECIALIST CONDUCTED A FULL IN-SERVICE TRAINING WITH HOSPITAL STAFF ON (B)(4) 2013 OVER THE PROPER USE AND HANDLING OF SCBIS.

    Description of Event or Problem · 1

    THE USER FACILITY REPORTED THAT THEY RECEIVED POSITIVE BIOLOGICAL INDICATOR (BI) RESULTS FROM THE SELF-CONTAINED BI INCLUDED IN A V-PRO STERILIZER LOAD. THE BI THAT REPORTEDLY FAILED WAS A STERIS VERIFY SCBI. THE CYCLE SUBJECT OF THE REPORTED EVENT COMPLETED SUCCESSFULLY. INSTRUMENTS IN THE REPORTED CYCLE WERE REPROCESSED AND NOT USED IN PATIENT PROCEDURES. THERE ARE NO INJURIES OR PROCEDURAL DELAYS/CANCELLATIONS REPORTED WITH THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    183987 VERIFY V24 SELF CONTAINED BI BIOLOGICAL INDICATOR FRC STERIS MEXICO, S. DE R.L. DE C.V. 130801A

    Patients

    Seq Age Sex Outcome Treatment
    1 Other