BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROG VALVE INLINE W SG

    MDR report key: 19054347 · Received April 5, 2024

    Report

    Report Number
    3013886523-2024-00103
    Event Type
    Malfunction
    Date Received
    April 5, 2024
    Report Date
    September 24, 2024
    Manufacturer
    INTEGRA LIFESCIENCES MANSFIELD
    Product Code
    JXG
    UDI-DI
    10381780519805
    PMA / PMN Number
    K053107
    Product Problem
    Yes
    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

    THE HAKIM VALVE (ID 823832) WAS RETURNED FOR EVALUATION. DEVICE HISTORY RECORD (DHR): THE PRODUCT CODE 823832 WITH LOT 6483273, CONFORMED TO THE SPECIFICATIONS WHEN RELEASED TO STOCK. FAILURE ANALYSIS: THE POSITION OF THE CAM WHEN VALVE WAS RECEIVED WAS ON SETTING 90 MMH2O. THE VALVE WAS VISUALLY INSPECTED; THE CONNECTOR WAS DISLODGED FROM THE NEEDLE CHAMBER. A LEAK WAS NOTED BETWEEN THE CONNECTOR AND HOUSING. ROOT CAUSE ANALYSIS - THE POSSIBLE ROOT CAUSE FOR THE ISSUE REPORTED BY THE CUSTOMER, COULD BE DUE TO IMPROPER HANDLING OF THE DEVICE.

    Description of Event or Problem · 0

    A FACILITY REPORTED A HAKIM VALVE (ID (B)(6)) WAS LEAKING CEREBROSPINAL FLUID. THE EVENT OCCURRED DURING THE PROCEDURE BEFORE IMPLANTATION SITE CLOSURE. THE EVENT DID NOT LED TO SURGICAL DELAY. THE PROCEDURE WAS COMPLETED WITH A REPLACEMENT PRODUCT AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1624888 PROG VALVE INLINE W SG CHPV WITH SG JXG INTEGRA LIFESCIENCES MANSFIELD 6483273 10381780519805

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown