BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPECIAL DEVICE UNITIZED PROGRA

    MDR report key: 10431964 · Received August 20, 2020

    Report

    Report Number
    3013886523-2020-00054
    Event Type
    Malfunction
    Date Received
    August 20, 2020
    Date of Event
    July 30, 2020
    Report Date
    July 31, 2020
    Manufacturer
    INTEGRA LIFESCIENCES SWITZERLAND SAR
    Product Code
    JXG
    PMA / PMN Number
    NI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    UNIQUE DEVICE IDENTIFICATION (UDI) : (B)(4). THE VALVE WAS RETURNED FOR EVALUATION: DEVICE HISTORY RECORD - LOT 3945858, 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 180MMH2O. THE VALVE WAS HYDRATED. THE VALVE PASSED THE TEST FOR FLUSHED, LEAK, REFLUX, SIPHON GUARD AND PRESSURE. THE CATHETERS WERE IRRIGATED, NO OCCLUSIONS NOTED. NO ROOT CAUSE COULD BE DETERMINED AS THE TECHNICIAN COULD NOT CONFIRM ANY PROBLEM WITH THE VALVE AT THE TIME OF INVESTIGATION. THE POTENTIAL CAUSE OF FAILURE FOR THE POOR FLOW PROBLEM REPORTED BY THE CUSTOMER COULD HAVE BEEN DUE TO BIOLOGICAL DEBRIS AND A BUILDUP OF PROTEIN, NO ISSUES WERE NOTED DURING THE INVESTIGATION.

    Additional Manufacturer Narrative · 1

    ATTEMPTS ARE BEING MADE TO OBTAIN ADDITIONAL INFORMATION. UPON COMPLETION OF THE INVESTIGATION, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    A PHYSICIAN REPORTED THE HAKIM VALVE WAS BLOWN OUT WITH A SYRINGE BEFORE IMPLANTATION. THE WATER FLOWED SLOWLY, SO THE PHYSICIAN DECIDED TO REPLACE IT WITH A NEW PRODUCT IN CASE OF VALVE FAILURE. THERE WAS NO SURGICAL DELAY OR ADVERSE CONSEQUENCE TO THE PATIENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    898886 SPECIAL DEVICE UNITIZED PROGRA CHPV WITH SG JXG INTEGRA LIFESCIENCES SWITZERLAND SAR 3945858

    Patients

    Seq Age Sex Outcome Treatment
    1