BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROG VALVE INLINE W SG

    MDR report key: 19588552 · Received June 21, 2024

    Report

    Report Number
    3013886523-2024-00174
    Event Type
    Injury
    Date Received
    June 21, 2024
    Date of Event
    May 30, 2024
    Report Date
    October 4, 2024
    Manufacturer
    INTEGRA LIFESCIENCES MANSFIELD
    Product Code
    JXG
    UDI-DI
    10886704041825
    PMA / PMN Number
    K053107
    Adverse Event
    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 82-3832 WITH LOT 6855345, SHOWED REPORT WHEN RELEASED TO STOCK. ALL FINISHED GOODS TEST RESULTS, INCLUDING ENDOTOXIN SATISFACTORILY MET THE REQUIREMENTS. FAILURE ANALYSIS - THE POSITION OF THE CAM WHEN VALVE WAS RECEIVED WAS ON SETTING 130 MMH2O. THE VALVE WAS VISUALLY INSPECTED; BIOLOGICAL DEBRIS WAS NOTED ON THE HOUSING, BASE PLATE AND MOTOR. NEEDLE HOLE WAS NOTED IN THE NEEDLE CHAMBER. THE VALVE WAS TESTED FOR PROGRAMMING, THE VALVE FAILED THE TEST. THE VALVE PASSED THE TEST FOR OCCLUSION, REFLUX AND SIPHON GUARD. THE VALVE WAS LEAK TESTED; THE LEAK TESTED PASSED. ONLY LEAKED FROM THE NEEDLE HOLE IN THE NEEDLE CHAMBER. THE PRESSURE TEST COULD NOT BE PERFORMED BECAUSE THE DEVICE IS NOT PROGRAMMED. THE VALVE WAS DISASSEMBLED: THE VALVE WAS VISUALLY INSPECTED UNDER MICROSCOPE AT APPROPRIATE MAGNIFICATION: BIOLOGICAL DEBRIS WAS FOUND ON THE RUBY BALL, MOTOR AND ON THE SEAT OF THE RUBY BALL. A VISUAL CHECK OF THE MAGNETIZATION MOTORS WAS CARRIED OUT; THE VALVE PASSED THE TEST. ROOT CAUSE ANALYSIS - THE POSSIBLE ROOT CAUSE FOR ¿THE PATIENT GOT FEVER¿ REPORTED BY THE CUSTOMER COULD BE LINKED TO THE PATIENT AND HOSPITAL SURROUNDINGS.

    Description of Event or Problem · 0

    THIS IS 1 OF 2 REPORTS LINKED TO MFG REPORT NUMBER 3013886523-2024-00175: A FACILITY REPORTED A HAKIM VALVE (ID 823832) AND A BACTISEAL CATHETER (ID 823072) WERE IMPLANTED ON (B)(6) 2024. ON (B)(6) 2024 THE PATIENT HAD FEVER AND CEREBROSPINAL FLUID (CSF) TESTED POSITIVE. THEREFORE, THE PATIENT RECEIVED AN ANTI-INFECTIVE THERAPY. ON (B)(6) 2024, THE PHYSICIAN CONDUCTED A REVISION PROCEDURE AND THE DEVICES WERE EXPLANTED AND REPLACED WITH A NEW HAKIM VALVE (ID 823832) AND THE BACTISEAL CATHETER (ID 823072).

    Description of Event or Problem · 0

    N/A

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1156888 PROG VALVE INLINE W SG CHPV WITH SG JXG INTEGRA LIFESCIENCES MANSFIELD 6855345 10886704041825

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Male Required Intervention BACTISEAL CATHETER (ID 823072)