BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROG VALVE INLINE

    MDR report key: 18301554 · Received December 11, 2023

    Report

    Report Number
    3013886523-2023-00433
    Event Type
    Injury
    Date Received
    December 11, 2023
    Date of Event
    November 22, 2023
    Report Date
    March 6, 2024
    Manufacturer
    INTEGRA LIFESCIENCES MANSFIELD
    Product Code
    JXG
    UDI-DI
    10886704041832
    PMA / PMN Number
    K053107
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    HAKIM VALVE (ID 823834) WAS RETURNED FOR EVALUATION. DEVICE HISTORY RECORD (DHR) - LOT CTCBG6, CONFORMED TO THE SPECIFICATIONS WHEN RELEASED TO STOCK. FAILURE ANALYSIS - THE VALVE WAS VISUALLY INSPECTED, BIOLOGICAL DEBRIS WERE NOTED IN THE HOUSING AND A NEEDLE HOLE IN THE NEEDLE CHAMBER WAS NOTED. THE VALVE PASSED THE TEST FOR PROGRAMMING, OCCLUSION AND REFLUX. THE VALVE PASSED THE TEST FOR LEAK, ONLY LEAK FROM THE NEEDLE HOLE. 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. THE POSSIBLE ROOT CAUSE FOR THE ISSUE REPORTED BY THE CUSTOMER, COULD BE DUE TO BIOLOGICAL DEBRIS AND PROTEIN BUILD UP INTERFERING WITH THE VALVE DEVICE IN VIEW OF THE BIOLOGICAL DEBRIS NOTED IN THE HOUSING.

    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

    THIS IS 1 OF 2 REPORTS LINKED TO MFG REPOT NUMBER 3013886523-2023-00434. A PHYSICIAN REPORTED A HAKIM VALVE (ID 823834) WAS IMPLANTED IN 2019 VIA VENTRICULOPERITONEAL (VP) SHUNT WITH SETTING 90 MMH2O. THE VALVE WAS USED WITH THE STRAIGHT CONNECTOR ID (823053). ON (B)(6) 2023, THE VALVE SETTING WAS CHANGED TO 30 MMH2O. HOWEVER, DUE TO THE RESULT OF PATENCY CHECK, THE SUSPICION OF BLOCKAGE WAS CONFIRMED. THEREFORE, THE HAKIM VALVE AND CONNECTOR WERE REMOVED AND REPLACED ON (B)(6) 2023. ACCORDING TO THE INFORMATION PROVIDED, IT IS UNKNOWN IF THE PATIENT HAD SIGNS AND SYMPTOMS DUE TO OBSTRUCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2137551 PROG VALVE INLINE CHPV JXG INTEGRA LIFESCIENCES MANSFIELD CTCBG6 10886704041832

    Patients

    Seq Age Sex Outcome Treatment
    1 21 YR Male SHUNT CONNECTOR TITANIUM STRL (ID 823053).