BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LUMBAR CATHETER ACCESSORY KIT (LCAK)

    MDR report key: 553966 · Received April 29, 2004

    Report

    Report Number
    9612007-2004-00035
    Event Type
    Malfunction
    Date Received
    April 29, 2004
    Date of Event
    March 7, 2004
    Report Date
    April 29, 2004
    Manufacturer
    INTEGRA NEUROSCIENCES IMPLANTS S.A.
    Product Code
    JXG
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    INVALID DATA

    Narratives

    Description of Event or Problem · 1

    A COPY OF USER FACILITY MANADATORY FDA FROM 3500A (REFERENCE NUMBER 24-0010-2004-0012) WAS RECEIVED. THE FOLLOWING WAS DOCUMENTED, UPON COMING IN THE NIGHT SHIFT NURESE HAD REPORTED THAT THE LUMBAR DRAIN WAS NOT DRAINING PT. NURSE OBSERVED THE DRAIN/DRAIN SITE ASSESSING THAT ALL CONNECTIONS AND CLAMPS WERE INTACT, AND FOUND THE DRAIN NOT DRAINING. THE RESIDENT WAS NOTIFIED OF THE DRAIN NOT FUNCTIONING PROPERLY. UPON ASSESSING THE DRAIN/DRAIN SITE, HE CONCLUDED THAT THE DRAIN/CATHETER HAD BROKEN AT THE SUTURE "HUB" SITE. UPON SPEAKING TO THE RESIDENT, HE FELT THAT THE "HUB" ACTING AS A FALCRUM CONTRIBUTED TO THE DRAIN/CATHETER BREAKING. A REMAINING PIECE OF THE BROKEN DRAIN/CATHETER REMAINED IN THE PT'S LUMBAR REGION AND REQUIRED SURGICAL INTERVENTION FOR REMOVAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LUMBAR CATHETER ACCESSORY KIT (LCAK) EXTERNAL DRAINAGE JXG INTEGRA NEUROSCIENCES IMPLANTS S.A. * UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 *