BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROG VALVE INLINE W SG 823832

    MDR report key: 24129708 · Received January 21, 2026

    Report

    Report Number
    3013886523-2026-00009
    Event Type
    Malfunction
    Date Received
    January 21, 2026
    Date of Event
    December 31, 2025
    Report Date
    February 27, 2026
    Manufacturer
    INTEGRA LIFESCIENCES MANSFIELD
    Product Code
    JXG
    UDI-DI
    10381780519805
    PMA / PMN Number
    K221840
    Product Problem
    Yes
    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 REVIEW: THE PRODUCT CODE 82-3832 WITH LOT 7392789 CONFORMED TO SPECIFICATIONS WHEN RELEASED TO STOCK. FAILURE ANALYSIS: THE POSITION OF THE CAM WHEN THE VALVE WAS RECEIVED WAS AT SETTING 160 MMH2O. THE VALVE WAS VISUALLY INSPECTED; THE SURFACE OF THE HOUSING ON THE SIPHON GUARD WAS CUT AND ANOTHER CUT ON THE CASING WAS NOTED (BETWEEN THE NEEDLE CHAMBER AND THE CAM MECHANISM). THE VALVE PASSED THE PROGRAMMING TEST. THE VALVE WAS NOT FLUSHED AS THE VALVE WAS TORN. THE VALVE FAILED THE LEAK TEST. THE VALVE WAS EXAMINED UNDER MICROSCOPE AT APPROPRIATE MAGNIFICATION: 2 CUT/TEARS IN THE SILICONE HOUSING WERE NOTED. ROOT CAUSE ANALYSIS: THE ROOT CAUSE FOR CSF LEAKING REPORTED BY THE CUSTOMER, IS DUE TO THE TEAR IN THE HOUSING. THE ROOT CAUSE FOR THE ¿TEAR MARK¿ COULD BE DUE A SHARP OR POINTED OBJECT COMING INTO CONTACT WITH THE VALVE IN VIEW OF THE TEAR MARK ON THE NEEDLE CHAMBER. AS NOTED IN THE SURGICAL PROCEDURE PRECAUTIONS SECTION IN IFU, SILICONE HAS A LOW CUT/TEAR RESISTANCE.

    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 HAKIM VALVE (ID 823832) WAS LEAKING CEREBROSPINAL FLUID (CSF) DURING PROCEDURE BEFORE IMPLANTATION SITE CLOSURE. THE EVENT DID NOT LED TO SURGICAL DELAY. THE PROCEDURE WAS COMPLETED WITH A REPLACEMENT PRODUCT AVAILABLE. THE PATIENT IS CURRENTLY IN STABLE CONDITION WITH NO COMPLICATIONS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    190075 PROG VALVE INLINE W SG 823832 INTERNAL CSF DRAINAGE JXG INTEGRA LIFESCIENCES MANSFIELD 7392793 10381780519805

    Patients

    Seq Age Sex Outcome Treatment
    1 32 YR Female