BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EXTERNAL CSF DRAINAGE, GREEN STRIPED PRESSURE TUBE

    MDR report key: 1051682 · Received May 19, 2008

    Report

    Report Number
    2648988-2008-00023
    Event Type
    Malfunction
    Date Received
    May 19, 2008
    Date of Event
    March 26, 2008
    Report Date
    May 19, 2008
    Manufacturer
    INTEGRA NEUROSCIENCES, PR
    Product Code
    JXG
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    OTHER

    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

    THE REPORTER STATED THAT LEAKING OF CEREBROSPINAL FLUID AT THE STOPCOCK TRANSDUCER CONNECTION WAS OBSERVED. THE DRAINAGE SYSTEM WAS IN USE SIX DAYS BEFORE IT LEAKED. THE LEAK WAS OBSERVED AT THE BEGINNING OF THE MORNING SHIFT. THE PATIENT HAD NEEDED AN EXTERNAL VENTRICULAR DRAIN AFTER HAVING A SUBARACHNOID HEMORRHAGE. THE PRODUCT PROBLEM DID NOT ADVERSELY AFFECT THE PATIENT'S CONDITION. THE DEVICE WAS NOT SAVED AND IS NOT AVAILABLE FOR EVALUATION. THE FACILITY REPORT TWO, (POSSIBLY THREE) OTHER INCIDENTS WITH THE SAME TYPE OF DEVICES LEAKING AT THE SAME SITE. TWO OF THESE ARE AVAILABLE FOR RETURN FOR EVALUATION. NO PATIENTS WERE ADVERSELY AFFECTED BY THESE EVENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EXTERNAL CSF DRAINAGE, GREEN STRIPED PRESSURE TUBE POLE MOUNT EXTERNAL DRAINAGE SYSTEM JXG INTEGRA NEUROSCIENCES, PR INS-8601 1073152

    Patients

    Seq Age Sex Outcome Treatment
    1