BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CERTS INLIN VLV W/UNIT BAC CAT

    MDR report key: 18694876 · Received February 13, 2024

    Report

    Report Number
    3013886523-2024-00036
    Event Type
    Injury
    Date Received
    February 13, 2024
    Date of Event
    January 15, 2024
    Report Date
    March 15, 2024
    Manufacturer
    INTEGRA LIFESCIENCES SWITZERLAND SAR
    Product Code
    JXG
    UDI-DI
    10886704071358
    PMA / PMN Number
    K143111
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    AN INVESTIGATION HAS BEEN INITIATED BASED ON THE REPORTED INFORMATION. UPON COMPLETION OF THE INVESTIGATION, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 0

    CERTAS VALVE WAS RETURNED FOR EVALUATION: DHR - LOT 4181011, CONFORMED TO THE SPECIFICATIONS WHEN RELEASED TO STOCK FAILURE ANALYSIS - THE VALVE WAS VISUALLY INSPECTED; NEEDLE HOLE IN THE NEEDLE CHAMBER WAS NOTED. THE VALVE PASSED THE TESTS PROGRAMMING, OCCLUSION, REFLUX AND PRESSURE. THE VALVE WAS LEAK TESTED; ONLY LEAKED FROM THE NEEDLE HOLE IN THE NEEDLE CHAMBER. ROOT CAUSE - NO ROOT CAUSE COULD BE DETERMINED FOR THE ISSUE REPORTED BY THE CUSTOMER AS THE TECHNICIAN COULD NOT CONFIRM ANY FUNCTIONAL ISSUES WITH THE VALVE AT THE TIME OF INVESTIGATION. A POSSIBLE ROOT CAUSE FOR THE ISSUE REPORTED BY THE CUSTOMER COULD BE DUE TO BIOLOGICAL DEBRIS AND PROTEIN BUILD UP INTERFERING WITH THE DEVICE. BUT AT THE TIME OF INVESTIGATION NO PROGRAMING ISSUES WERE NOTED.

    Description of Event or Problem · 0

    A FACILITY REPORTED A CERTAS VALVE (ID 828803) "COULD NO LONGER BE ADJUSTED", THEREFORE IT WAS EXPLANTED.

    Description of Event or Problem · 0

    N/A.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    765906 CERTS INLIN VLV W/UNIT BAC CAT CERTAS PLUS W/ BACTISEAL JXG INTEGRA LIFESCIENCES SWITZERLAND SAR 4181011 10886704071358

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown