BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROG VALVE INLINE W SG

    MDR report key: 23435930 · Received October 31, 2025

    Report

    Report Number
    3013886523-2025-00297
    Event Type
    Injury
    Date Received
    October 31, 2025
    Date of Event
    August 19, 2025
    Report Date
    December 25, 2025
    Manufacturer
    INTEGRA LIFESCIENCES MANSFIELD
    Product Code
    JXG
    UDI-DI
    10381780519805
    PMA / PMN Number
    K221840
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    UPDATED FIELDS: D4, D9, G3, G6, H2, H3, H4, H6, H11. THE HAKIM VALVE (ID 823832) WAS RETURNED FOR EVALUATION. DEVICE HISTORY RECORD (DHR) - THE PRODUCT CODE 82-3832 WITH LOT 7302947 CONFORMED TO SPECIFICATIONS WHEN RELEASED TO STOCK. FAILURE ANALYSIS - THE POSITION OF THE CAM WHEN THE VALVE WAS RECEIVED WAS AT SETTING 60 MMH2O. THE VALVE WAS VISUALLY INSPECTED, BIOLOGICALS DEBRIS OBSERVED IN THE CASING. THE VALVE PASSED THE TEST FOR OCCLUSION, LEAK, REFLUX AND SIPHON GUARD. THE VALVE FAILED THE TEST FOR PROGRAMMING. THE VALVE COULD NOT BE PRESSURE TESTED AS THE CAM WAS BLOCKED AT 60MMH2O. THE VALVE WAS DISMANTLED AND EXAMINED UNDER MICROSCOPE AT APPROPRIATE MAGNIFICATION: BIOLOGICAL DEBRIS WERE NOTED ON THE PLATE, BALL SEAT, MOTOR AND THE BALL. THE CAM MAGNETS WERE CONTROLLED AND PASSED THE TEST. ROOT CAUSE ANALYSIS - THE ROOT CAUSE FOR THE PROGRAMMING ISSUE OBSERVED DURING INVESTIGATION AND REPORTED ISSUE (OBSTRUCTION) IS DUE TO BIOLOGICALS DEBRIS. THE PROBABLE ROOT CAUSE FOR THE "INFECTION" ISSUE REPORTED BY THE CUSTOMER COULD BE LINKED TO THE PATIENT AND HOSPITAL SURROUNDINGS.

    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 REPORT NUMBER: 3013886523-2025-00298. A FACILITY REPORTED A HAKIM VALVE (ID 823832) AND A CODMAN BACTISEAL CATHETER (ID 823072) WERE IMPLANTED ON AUGUST 13, AND THE PROCEDURE PROCEEDED WITHOUT COMPLICATIONS. ON (B)(6) THE PATIENT DEVELOPED A MILD FEVER; THEREFORE, A POSTOPERATIVE EXPLORATION WAS PERFORMED, WHICH REVEALED TUBE OBSTRUCTION. THE SHUNT AND CATHETER WERE REMOVED BUT NOT REPLACED, AND ANTI-INFECTION TREATMENT WAS ADMINISTERED. THE PATIENT SUBSEQUENTLY RECOVERED WELL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2084702 PROG VALVE INLINE W SG CHPV WITH SG JXG INTEGRA LIFESCIENCES MANSFIELD 7302947 10381780519805

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Female Required Intervention BACTISEAL CATHETER (ID 823072).