BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROG VALVE INLINE W SG

    MDR report key: 20042836 · Received August 22, 2024

    Report

    Report Number
    3013886523-2024-00248
    Event Type
    Malfunction
    Date Received
    August 22, 2024
    Date of Event
    July 30, 2024
    Report Date
    October 24, 2024
    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 RECORD (DHR) - THE PRODUCT CODE 82-8815 WITH LOT 7152715, CONFORMED TO THE SPECIFICATIONS WHEN RELEASED TO STOCK. FAILURE ANALYSIS - THE POSITION OF THE CAM WHEN VALVE WAS RECEIVED WAS ON SETTING 100 MMH2O. THE VALVE WAS VISUALLY INSPECTED; THE NEEDLE GUARD WAS LITTLE DISLODGED. THE VALVE WAS LEAK TESTED NO OTHER LEAK THAN THE NEEDLE GUARD WAS NOTED. THE COMPLAINT WAS CONFIRMED. ROOT CAUSE ANALYSIS - THE ROOT CAUSE FOR THE ISSUE REPORTED BY THE CUSTOMER IS DUE TO THE DISLODGED NEEDLE GUARD, AS NOTED IN THE IFU. DO NOT FOLD OR BENT THE VALVE, FOLDING OR BENDING MIGHT CAUSE RUPTURE OF THE SILICONE HOUSING, NEEDLE GUARD DISC DISLODGEMENT OR OCCLUSION OF THE FLUID PATHWAY.

    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 HAKIM VALVE (ID 823832) WAS LEAKING CEREBROSPINAL FLUID (CSF) FROM THE NEEDLE CHAMBER DURING THE PROCEDURE. THE PROCEDURE WAS COMPLETED WITH A REPLACEMENT PRODUCT AVAILABLE. NO PATIENT INJURY REPORTED, AND THE EVENT DID NOT LEAD TO SURGICAL DELAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1312775 PROG VALVE INLINE W SG CHPV WITH SG JXG INTEGRA LIFESCIENCES MANSFIELD 7152715 10381780519805

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male