BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DEFENDO SINGLE USE VALVE KIT

    MDR report key: 22977110 · Received September 5, 2025

    Report

    Report Number
    1651395-2025-00018
    Event Type
    Malfunction
    Date Received
    September 5, 2025
    Date of Event
    August 5, 2025
    Report Date
    September 5, 2025
    Manufacturer
    MEDIVATORS INC.
    Product Code
    NWU
    UDI-DI
    00677964092992
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION OF THE EVENT IS CURRENTLY IN PROGRESS. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN ADDITIONAL INFORMATION BECOMES AVAILABLE. UDI RELATED DATA CLARIFICATION: THE LOT/SERIAL NUMBER IS UNKNOWN; THEREFORE, THE APPLICABLE PRODUCTION IDENTIFIERS WERE NOT INCLUDED IN THE MDR.

    Additional Manufacturer Narrative · 0

    THE DEVICES SUBJECT OF THE EVENT WERE NOT AVAILABLE FOR EVALUATION. WITHOUT THE RETURN AND EVALUATION OF THE DEVICES, THE CAUSE OF THE REPORTED EVENT CANNOT BE DETERMINED. THE USER FACILITY WAS UNABLE TO PROVIDE THE LOT NUMBER FOR THE DEFENDO DISPOSABLE BIOPSY VALVE; THEREFORE, A REVIEW OF THE DEVICE HISTORY RECORD COULD NOT BE PERFORMED. STERIS WILL CONTINUE TO MONITOR FOR SIMILAR EVENTS TO ENSURE THE PRODUCT CONTINUES TO PERFORM AS EXPECTED. NO ADDITIONAL ISSUES HAVE BEEN REPORTED.

    Description of Event or Problem · 0

    THE USER FACILITY REPORTED THAT THE BIOPSY VALVE TO THEIR DEFENDO SINGLE USE VALVE KIT LEAKED AND SPRAYED WATER ONTO USER FACILITY PERSONNEL. NO REPORT OF INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    306474 DEFENDO SINGLE USE VALVE KIT DEFENDO SINGLE USE VALVE KIT NWU MEDIVATORS INC. 100322 00677964092992

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown