BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CERTAS PLUS INLINE VALVE ONLY

    MDR report key: 18787811 · Received February 27, 2024

    Report

    Report Number
    3013886523-2024-00051
    Event Type
    Injury
    Date Received
    February 27, 2024
    Date of Event
    January 29, 2024
    Report Date
    April 11, 2024
    Manufacturer
    INTEGRA LIFESCIENCES SWITZERLAND SAR
    Product Code
    JXG
    UDI-DI
    10886704079002
    PMA / PMN Number
    K143111
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    THE CERTAS VALVE (ID (B)(6)) WAS RETURNED FOR EVALUATION. DEVICE HISTORY RECORD (DHR) - THE PRODUCT CODE (B)(6) WITH LOT 200113, CONFORMED TO THE SPECIFICATIONS WHEN RELEASED TO STOCK. FAILURE ANALYSIS - THE POSITION OF THE CAM WHEN VALVE WAS RECEIVED WAS AT SETTING 3. THE CATHETERS WERE IRRIGATED, NO OCCLUSION NOTED. THE VALVE WAS VISUALLY INSPECTED, NEEDLE HOLE WAS NOTED IN THE NEEDLE CHAMBER. THE VALVE WAS HYDRATED. THE VALVE WAS LEAK TESTED AND ONLY LEAKED FROM THE NEEDLE HOLE IN THE NEEDLE CHAMBER. THE VALVE PASSED THE TEST FOR PROGRAMMING, OCCLUSION, SIPHON GUARD AND PRESSURE. ROOT CAUSE ANALYSIS - NO ROOT CAUSE COULD BE DETERMINED AS THE TECHNICIAN COULD NOT CONFIRM ANY PROBLEM WITH THE VALVE AT THE TIME OF INVESTIGATION.

    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.

    Description of Event or Problem · 0

    N/A.

    Description of Event or Problem · 0

    A FACILITY REPORTED A CERTAS VALVE (ID 828800PL) HAD BEEN PROGRAMMED INCORRECTLY WITH A MEDTRONIC SHUNT BY ACCIDENT AND THE PHYSICIAN SAID IT WAS FAULTY. THE VALVE WAS IMPLANTED IN A 69 YEAR OLD MALE PATIENT ON (B)(6) 2018 WITH SETTING OF 3. THE VALVE FAILURE WAS DISCOVERED WHEN PATIENT WAS ADMITTED IN THE EMERGENCY ROOM DUE TO DIZZINESS. THE VALVE WAS EXPLANTED AND REPLACED WITH A NEW VALVE ON (B)(6) 2024. PATIENT IS DOING GOOD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    119114 CERTAS PLUS INLINE VALVE ONLY CERTAS PLUS JXG INTEGRA LIFESCIENCES SWITZERLAND SAR 200113 10886704079002

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Male