BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SUBDURAL CATHETER

    MDR report key: 527710 · Received February 25, 2004

    Report

    Report Number
    9612007-2004-00012
    Event Type
    Malfunction
    Date Received
    February 25, 2004
    Date of Event
    December 26, 2003
    Report Date
    February 25, 2004
    Manufacturer
    INTEGRA NEUROSCIENCES IMPLANTS S.A.
    Product Code
    GWM
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHARMACIST

    Narratives

    Description of Event or Problem · 1

    DURING DRAINAGE WITH A SUBDURAL CATHETER A BREAK WAS NOTED AT THE JUNCTION OF THE CATHETER AND THE RESERVOIR. THE RESERVOIR WAS DISCARDED, AND A NEW ONE WAS CONNECTED TO THE CATHETER. NO PT IMPACT WAS REPORTED. THE SALES REP MET THE NURSE WHO ENCOUNTERED THE PROBLEM IN FEBRUARY 2004; THE BREAKAGE OCCURRED AT THE LEVEL OF THE RESERVOIR DRAINAGE PORT USED TO EMPTY THE RESERVOIR, WHEN THE RESERVOIR WAS BEING EMPTIED. THE USER USES A SYRINGE TO ASPIRATE AND MEASURE EXACTLY THE DRAINED VOLUME. NOTE: THIS HOSPITAL STAFF IS USED TO THE DEVICE (USED AROUND TWICE PER WEEK).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SUBDURAL CATHETER ICP MONITORING GWM INTEGRA NEUROSCIENCES IMPLANTS S.A. * 0121700

    Patients

    Seq Age Sex Outcome Treatment
    1 *