BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNKNOWN EXACTA EDMS DEVICE

    MDR report key: 3900882 · Received June 27, 2014

    Report

    Report Number
    2021898-2014-00219
    Event Type
    Malfunction
    Date Received
    June 27, 2014
    Report Date
    May 30, 2014
    Manufacturer
    MEDTRONIC NEUROSURGERY
    Product Code
    GWM
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT HAS NOT BEEN RETURNED. THEREFORE AN EVALUATION OF DEVICE PERFORMANCE WAS NOT POSSIBLE. A REVIEW OF THE MAUNFACTURING 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.

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS PATENT. IT DID NOT MEET THE REQUIREMENTS FOR LEAK TESTING SINCE THE MAIN LINE TUBING WAS DISCONNECTED FROM THE MAIN LINE STOPCOCK. ADHESIVE WAS OBSERVED IN THE INTERIOR OF THE TUBING TO LUER CONNECTOR. A REVIEW OF THE MANUFACTURING RECORDS WAS NOT POSSIBLE AS NO LOT NUMBER WAS PROVIDED. ALL EXACTA EDMS DEVICES ARE 100% LEAK TESTED AT THE TIME OF MANUFACTURE. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED TO MEDTRONIC NEUROSURGERY THAT THE TUBING BECAME SEPARATED FROM THE LUER LOCK CONNECTOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    376548 UNKNOWN EXACTA EDMS DEVICE DEVICE, MONITORING, INTRACRANIAL PRESSURE GWM MEDTRONIC NEUROSURGERY UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1