BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BECKER EDMS, BLUE CAP, STOPCOCK BELOW DRIP CHAMBER

    MDR report key: 3873304 · Received June 13, 2014

    Report

    Report Number
    2021898-2014-00202
    Event Type
    Malfunction
    Date Received
    June 13, 2014
    Date of Event
    May 11, 2014
    Report Date
    May 15, 2014
    Manufacturer
    MEDTRONIC NEUROSURGERY
    Product Code
    JXG
    PMA / PMN Number
    K984053
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT WAS UNAVAILABLE FOR RETURN. THEREFORE AN EVALUATION OF THE DEVICE PERFORMANCE WAS NOT POSSIBLE. A REVIEW OF THE MANUFACTURING RECORDS WAS NOT POSSIBLE AS NO LOT NUMBER WAS PROVIDED. (B)(4).

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    IT WAS REPORTED TO MEDTRONIC NEUROSURGERY THAT WHILE CHANGING THE PATIENT¿S POSITION, THE PROXIMAL TUBING FROM THE DEVICE SLIPPED OUT OF THE STOPCOCK AT THE CSF COLLECTION PORT. ACCORDING TO THE REPORT, THE PATIENT DID NOT INCUR AN INJURY AS A RESULT OF THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    349541 BECKER EDMS, BLUE CAP, STOPCOCK BELOW DRIP CHAMBER SHUNT, CENTRAL NERVOUS SYSTEM AND COMPONENTS JXG MEDTRONIC NEUROSURGERY UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1