BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LUMBAR CATH. ACCESS KIT (LCAK)

    MDR report key: 3050646 · Received March 14, 2013

    Report

    Report Number
    9612007-2013-00009
    Event Type
    Malfunction
    Date Received
    March 14, 2013
    Date of Event
    December 23, 2012
    Report Date
    March 14, 2013
    Manufacturer
    INTEGRA NEUROSCIENCES IMPLANTS SA
    Product Code
    JXG
    PMA / PMN Number
    K910853
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE INVOLVED IN THE REPORTED INCIDENT IS NOT EXPECTED TO BE RECEIVED FOR EVAL. AN INVESTIGATION HAS BEEN INITIATED BASED UPON THE REPORTED INFO.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED INVOLVING A GUIDEWIRE AND A LUMBAR CATHETER. THE DESCRIPTION OF THE INCIDENT WAS: "EXTREME DIFFICULTY REMOVING THE GUIDEWIRE FROM THE CATHETER, DESPITE THE HEAVY AND PROLONGED WASHING OF THE CATHETER AND GUIDEWIRE ITSELF. A SECOND ATTEMPT AT POSITIONING WAS NECESSARY, HOWEVER, THE SAME CATHETER WAS REPOSITIONED AND REPLACED FOR LUMBAR DRAINAGE." THE PRODUCT IS NOT AVAILABLE FOR EVAL AND THE LOT NUMBER IS NOT KNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    108482 LUMBAR CATH. ACCESS KIT (LCAK) EXTERNAL DRAINAGE ACCESSORIES JXG INTEGRA NEUROSCIENCES IMPLANTS SA

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR