BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BECKER EDMS II

    MDR report key: 2805725 · Received October 22, 2012

    Report

    Report Number
    2021898-2012-00333
    Event Type
    Malfunction
    Date Received
    October 22, 2012
    Date of Event
    August 6, 2010
    Report Date
    August 25, 2010
    Manufacturer
    MEDTRONIC NEUROSURGERY
    Product Code
    JXG
    PMA / PMN Number
    K984053
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TW
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE 12 INCH BLUE STRIPED PATIENT LINE TUBING WAS DISCONNECTED FROM THE MALE LUER CONNECTOR OF THE STOPCOCK. IT IS UNKNOWN HOW OR WHEN THE DAMAGE OCCURRED. MEDTRONIC NEUROSURGERY HAS RECEIVED NO OTHER COMPLAINTS FOR THIS LOT NUMBER AND A REVIEW OF THE MANUFACTURING RECORDS SHOWED NO ANOMALIES. NO IMPACT TO THE PATIENT WAS REPORTED.

    Description of Event or Problem · 1

    IT WAS REPORTED TO MEDTRONIC NEUROSURGERY THAT THE 3-WAY STOPCOCK WAS FOUND TO BE DISCONNECTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BECKER EDMS II JXG - SHUNT, CENTRAL NERVOUS SYSTEM AND COMPONENTS JXG MEDTRONIC NEUROSURGERY UNK

    Patients

    Seq Age Sex Outcome Treatment
    1