BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCUDRAIN WITHOUT THE ANTI-REFLUX VALVE

    MDR report key: 2043298 · Received February 25, 2011

    Report

    Report Number
    2648988-2011-00006
    Event Type
    Malfunction
    Date Received
    February 25, 2011
    Report Date
    February 25, 2011
    Manufacturer
    INTEGRA NEUROSCIENCES PR
    Product Code
    JXG
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    THE HEALTHCARE PROVIDER PLACED THE VENTRICULAR CATHETER, ATTACHED THE EXTERNAL VENTRICULAR DRAINAGE (EVD) AND THE UNIT WAS SET TO 20 IN RECOVERY. WHEN THE PT WAS SEEN APPROX 5-10 MINS LATER THE FOLLOWING WAS NOTED: THE TUBING FROM THE TOP OF THE BURETTE WAS BROKEN. THE PT WAS NOT INJURED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACCUDRAIN WITHOUT THE ANTI-REFLUX VALVE NA JXG INTEGRA NEUROSCIENCES PR 10100-701-0302/10

    Patients

    Seq Age Sex Outcome Treatment
    1