BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IN LINE HAKIM UNITIZED PROGRAM

    MDR report key: 16765913 · Received April 18, 2023

    Report

    Report Number
    3013886523-2023-00113
    Event Type
    Injury
    Date Received
    April 18, 2023
    Date of Event
    April 3, 2023
    Report Date
    June 9, 2023
    Manufacturer
    INTEGRA LIFESCIENCES SWITZERLAND SAR
    Product Code
    JXG
    UDI-DI
    10886704066477
    PMA / PMN Number
    NI
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    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

    UPDATED FIELDS: D4, D9, G3, G6, H2, H3, H4, H6, H10. THE HAKIM VALVE (ID NS9009) HAS BEEN RETURNED FOR EVALUATION. DEVICE HISTORY RECORD (DHR) - THE PRODUCT CODE NS9009 WITH LOT 4113080, CONFORMED TO THE SPECIFICATIONS WHEN RELEASED. FAILURE ANALYSIS - THE POSITION OF THE CAM WHEN VALVE WAS RECEIVED WAS ON SETTING 110 MMH2O. THE VALVE WAS VISUALLY INSPECTED AND DEBRIS BIOLOGICAL WAS NOTED ON THE CAM. THE VALVE WAS HYDRATED. THE VALVE PASSED THE TEST FOR PROGRAMMING, OCCLUSION, LEAKS AND REFLUX. THE VALVE WAS DRIED. THE VALVE TESTED FOR PRESSURE AND FAILED THE TEST. THE VALVE WAS DISASSEMBLED. THE VALVE WAS VISUALLY INSPECTED UNDER MICROSCOPE AT APPROPRIATE MAGNIFICATION: BIOLOGICAL DEBRIS WAS FOUND ON THE SPRING, ON THE RUBY BALL AND ON THE SEAT OF THE RUBY BALL. THE ROOT CAUSE FOR THE ISSUE REPORTED BY THE CUSTOMER IS DUE TO BIOLOGICAL DEBRIS FOUND ON THE RUBY BALL AND ON THE CAM / BALL ARM ASSEMBLY AS WELL AS THE RC, THE DEBRIS WAS STOPPING THE RUBY BALL FROM BEING SEATED CORRECTLY.

    Description of Event or Problem · 0

    A PHYSICIAN REPORTED A HAKIM VALVE (NS9009) WAS IMPLANTED VIA LUMBAR PERITONEAL (LP) SHUNT IN (B)(6) 2023 WITH UNKNOWN SETTING. THE VALVE WAS USED WITH THE SILASCON LUMBAR CATHETER (MANUFACTURED BY KANEKA, PRODUCT CODE: 702-JJ). IN MARCH, UNDER-DRAINAGE WAS CONFIRMED BY DIAGNOSTIC IMAGING, SO AN ATTEMPT WAS MADE TO CHANGE THE SET PRESSURE, BUT IT WAS NOT POSSIBLE. ACCORDING TO INFORMATION PROVIDED, IT IS UNKNOWN IF THE PATIENT EXPERIENCED ANY SIGNS AND SYMPTOMS. THE VALVE WAS REMOVED AND REPLACED ON (B)(6), 2023.

    Description of Event or Problem · 0

    N/A.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1033218 IN LINE HAKIM UNITIZED PROGRAM CHPV JXG INTEGRA LIFESCIENCES SWITZERLAND SAR 10886704066477

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Male