BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROG VALVE INLINE W SG

    MDR report key: 15668358 · Received October 25, 2022

    Report

    Report Number
    3013886523-2022-00485
    Event Type
    Injury
    Date Received
    October 25, 2022
    Date of Event
    October 7, 2022
    Report Date
    December 14, 2022
    Manufacturer
    INTEGRA LIFESCIENCES SWITZERLAND SAR
    Product Code
    JXG
    UDI-DI
    10381780519232
    PMA / PMN Number
    K053107
    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

    THE HAKIM VALVE (ID 823842) WAS RETURNED FOR EVALUATION. DEVICE HISTORY RECORD (DHR) - THE PRODUCT CODE 82-3162 WITH LOT 5822409, CONFORMED TO THE SPECIFICATIONS WHEN RELEASED TO STOCK. FAILURE ANALYSIS - THE VALVE WAS VISUALLY INSPECTED: NO DEFECTS NOTED. THE POSITION OF THE CAM WHEN VALVE WAS RECEIVED WAS 30MMH2O. THE VALVE WAS HYDRATED. THE VALVE WAS LEAK TESTED AND NO LEAKS NOTED. THE VALVE PASSED THE TEST FOR PROGRAMMING, OCCLUSION, REFLUX, SIPHON GUARD AND PRESSURE. NO ROOT CAUSE COULD BE DETERMINED AS THE TECHNICIAN COULD NOT CONFIRM ANY PROBLEMS WITH THE VALVE AT THE TIME OF INVESTIGATION. THE ROOT CAUSE FOR THE "INFECTION" ISSUE REPORTED BY THE CUSTOMER COULD BE LINKED TO THE PATIENT AND HOSPITAL SURROUNDINGS, AS NO ISSUE WAS NOTED WITH THE STERILIZATION CERTIFICATE WHEN RELEASED ON THE 5TH OCTOBER 2021. THE POSSIBLE ROOT CAUSE FOR THE ¿OBSTRUCTED,¿ ISSUE REPORTED BY THE CUSTOMER, COULD BE DUE BIOLOGICAL DEBRIS AND PROTEIN BUILD UP INTERFERING WITH THE VALVE MECHANISM, BUT AT THE TIME OF INVESTIGATION NO OCCLUSIONS WERE NOTED WITH THE VALVE.

    Description of Event or Problem · 0

    THIS IS 2 OF 2 REPORTS (SAME VALVE, DIFFERENT EVENTS) LINKED TO MFG REPORT NUMBER: 3013886523-2022-00484. A PHYSICIAN REPORTED A HALIM VALVE (ID 823842) WAS IMPLANTED VIA V-P SHUNT ON (B)(6) 2022 WITH UNKNOWN SETTING. ON (B)(6) 2022 A SURGERY WAS PERFORMED TO CORRECT THE POSITION OF THE PERITONEAL CATHETER. EXTERNAL DRAINAGE WAS PERFORMED VIA A VALVE ON (B)(6) 2022 DUE TO INFECTION. THE VALVE WAS OBSTRUCTED AND THE CEREBROSPINAL FLUID COULD NOT BE DISCHARGED; THEREFORE, THE VALVE WAS REMOVED, ONLY THE RESERVOIR WAS REPLACED. ACCORDING TO REPORTER IT IS UNKNOWN IF THE INFECTION WAS RELATED TO THE VALVE. THIS REPORT IS FOR THE VALVE OBSTRUCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2509703 PROG VALVE INLINE W SG CHPV WITH SG JXG INTEGRA LIFESCIENCES SWITZERLAND SAR 823162 5822409 10381780519232

    Patients

    Seq Age Sex Outcome Treatment
    1 5 MO Unknown