BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STAINLESS STEEL CONNECTORS

    MDR report key: 3959809 · Received June 27, 2014

    Report

    Report Number
    9612007-2014-00018
    Event Type
    Malfunction
    Date Received
    June 27, 2014
    Report Date
    June 4, 2014
    Manufacturer
    INTEGRA NEUROSCIENCES IMPLANTS S.A.
    Product Code
    JXG
    PMA / PMN Number
    K861377
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DC, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    TO DATE, THE DEVICE INVOLVED IN THE REPORTED INCIDENT HAS NOT BEEN RECEIVED FOR EVALUATION. AN INVESTIGATION HAS BEEN INITIATED BASED UPON THE REPORTED INFORMATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE TUBING DID NOT STAY ATTACHED TO THE THREE PORT STAINLESS STEEL CONNECTOR. THE CONNECTOR WAS REMOVED AND WAS REPLACED WITH ANOTHER ONE THAT HELD THE TUBING. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    376888 STAINLESS STEEL CONNECTORS VALVE ACCESSORIES JXG INTEGRA NEUROSCIENCES IMPLANTS S.A. 184146

    Patients

    Seq Age Sex Outcome Treatment
    1