BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BECKER EDMS II

    MDR report key: 3180234 · Received June 13, 2013

    Report

    Report Number
    2021898-2013-00209
    Event Type
    Malfunction
    Date Received
    June 13, 2013
    Date of Event
    April 2, 2013
    Report Date
    April 10, 2013
    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 MAINLINE STOPCOCK OF THE RETURNED PRODUCT WAS FOUND TO BE STABLY ATTACHED TO THE DEVICE AND FUNCTIONING PROPERLY. THEREFORE THE CONDITIONS OF THE COMPLAINT COULD NOT BE DUPLICATED BY LABORATORY PERSONNEL. A CRACK WAS OBSERVED ON THE PATIENT LINE STOPCOCK. THE CRACK WAS NOTED TO BE LEAKING DURING THE LEAK CHECK. THE PATIENT LINE TUBING WAS DISCONNECTED FROM THE DISTAL LUER LOCK. THERE WAS GLUE PRESENT ON THE LINE AND IN THE LUER LOCK CONNECTION. TAPE FROM AN UNKNOWN SOURCE WAS WRAPPED AROUND THE LUER LOCK-PATIENT LINE CONNECTIONS. THE LUER LOCK-PATIENT LINE CONNECTIONS DID NOT LEAK DURING THE LEAK CHECK. THE DRAINAGE LINE'S LUER LOCK WAS DAMAGED. THE DAMAGE CAUSED THE DEVICE TO LEAK OUT OF THE DRAINAGE LINE-DRAINAGE BAG CONNECTION. IT IS UNKNOWN HOW OR WHEN THESE DAMAGES OCCURRED. THE INSTRUCTIONS FOR USE THAT ACCOMPANY THE DEVICE STATE THAT "IN ORDER TO AVOID POSSIBLE CRACKING OF THE LUER CONNECTORS AFTER CLEANING WITH ALCOHOL, ALLOW TO AIR DRY COMPLETELY PRIOR TO CONNECTING SYSTEM." A REVIEW OF THE MANUFACTURING RECORDS SHOWED NO ANOMALIES.

    Description of Event or Problem · 1

    IT WAS REPORTED TO MEDTRONIC NEUROSURGERY THAT THE MAIN SYSTEM STOPCOCK OF THE DEVICE WAS LOOSE AND THAT THE ONE-WAY VALVE OF THE DRAINAGE BAG WAS LOOSE AND LEAKING. IT WAS ALSO REPORTED THAT THERE WAS NO INJURY TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    268078 BECKER EDMS II JXG - SHUNT, CENTRAL NERVOUS SYSTEM AND COMPONENTS JXG MEDTRONIC NEUROSURGERY 11785711

    Patients

    Seq Age Sex Outcome Treatment
    1