BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCUDRAIN WITH ANTI-REFLUX VALVE

    MDR report key: 1960358 · Received December 16, 2010

    Report

    Report Number
    2648988-2010-00097
    Event Type
    Malfunction
    Date Received
    December 16, 2010
    Report Date
    December 16, 2010
    Manufacturer
    INTEGRA NEUROSCIENCES PR
    Product Code
    JXG
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    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

    IT WAS REPORTED THAT THE NURSE CONNECTED THE TUBING TO THE PT. WHEN THE BURETTE WAS APPLIED, THE NURSE NOTICED THAT FLUID STARTED LEAKING FROM THE CONNECTION BETWEEN THE TUBING AND THE TOP OF THE BURETTE. IT APPEARED THAT THE CONNECTION BETWEEN THE TUBING AND THE TOP OF THE BURETTE WAS SNAPPED AT THE CONNECTION WHERE THE TUBING GOES INTO THE BURETTE. THE NURSE IMMEDIATELY STOPPED THE PROCEDURE. A NEW PACKAGE WAS OPENED. THE REPLACEMENT HAD NO LEAKAGE ISSUES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACCUDRAIN WITH ANTI-REFLUX VALVE NA JXG INTEGRA NEUROSCIENCES PR 1100004

    Patients

    Seq Age Sex Outcome Treatment
    1