BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CSF DRAINAGE SYSTEM W/VINYL MEASURING STRIP

    MDR report key: 1935457 · Received November 10, 2010

    Report

    Report Number
    2648988-2010-00088
    Event Type
    Malfunction
    Date Received
    November 10, 2010
    Date of Event
    October 8, 2010
    Report Date
    November 10, 2010
    Manufacturer
    INTEGRA NEUROSCIENCES PR
    Product Code
    JXG
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DATE, THE DEVICE INVOLVED IN THE REPORTED INCIDENT HAS NOT BEEN RECEIVED FOR EVAL. AN INVESTIGATION HAS BEEN BASED UPON THE REPORTED INFO.

    Description of Event or Problem · 1

    A CSF DRAINAGE SYSTEM (10140) WITH VINYL MEASURING STRIP WAS INVOLVED IN AN INCIDENT WHICH WAS DESCRIBED AS FOLLOWS; AN (B)(6) YEAR-OLD, FEMALE, PT, WHO WAS POST OPERATIVE LAMINECTOMY, HAD A CSF DRAINAGE SYSTEM (EXTERNAL INTEGRA MONITOR DRAIN) PLACED. IN AN ATTEMPT TO EMPTY THE BURETTE INTO THE DRAIN BAG, THE BURETTE WOULD NOT DRAIN INTO THE BAG AFTER OPENING THE STOPCOCK. A SYRINGE WAS ATTACHED TO THE PORT NEAR THE STOPCOCK, AND NO CSF COULD BE DRAINED FROM THE PORT INTO THE SYRINGE. FINALLY A NEEDLE WAS INSERTED TO MANUALLY PERFORATE THE STOPCOCK TO ALLOW EMPTYING OF THE BURETTE. THE PT DID NOT EXPERIENCE AN INJURY AS A RESULT OF THIS INCIDENT, NO REVISION WAS REQUIRED AND THERE WAS NO DELAY IN THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CSF DRAINAGE SYSTEM W/VINYL MEASURING STRIP NA JXG INTEGRA NEUROSCIENCES PR 1102765 OR 1102399

    Patients

    Seq Age Sex Outcome Treatment
    1 85 YR