BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DISPOSABLE SCALP NEEDLE ELECTRODES

    MDR report key: 5109965 · Received September 29, 2015

    Report

    Report Number
    3004827015-2015-00001
    Event Type
    Malfunction
    Date Received
    September 29, 2015
    Date of Event
    September 11, 2015
    Report Date
    September 28, 2015
    Manufacturer
    ALPINE BIOMED APS
    Product Code
    GXZ
    PMA / PMN Number
    K932059
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    REGISTERED INTERNALLY AS A (B)(4)) FOR INVESTIGATIVE PURPOSES. THE CONTRACT MANUFACTURER SP MEDICAL HAVE ALSO BEEN ISSUED A SUPPLIER CORRECTIVE ACTION REPORT (SCAR) TO PROVIDE DETAILS AND RESULTS OF THEIR INVESTIGATION INTO SEPARATION OF THE NEEDLES AND ALL RESULTING CORRECTIVE AND PREVENTATIVE ACTION ((B)(4)) THE DEVICE HISTORY RECORD FOR THIS BATCH WAS PROVIDED BY (B)(6) MEDICAL AND REVIEWED. IN PROCESS TESTING AND INSPECTIONS WERE REVIEWED. ALL SAMPLES TAKEN FOR TESTS GAVE ACCEPTABLE RESULT. NO ISSUES WERE NOTED. NO REWORK OR SORT PERFORMED ON THIS LOT. NO NCR'S NOTED FOR THIS LOT.

    Description of Event or Problem · 1

    CUSTOMER REPORTED FINDING A BROKEN NEEDLE ON OPENING A BOX OF SCALP NEEDLES AND ANOTHER NEEDLE FROM THE SAME BOX BROKE WHILE IN THE PATIENTS HEAD. THE NEEDLE CAME APART FROM THE HUB DURING USE, LEAVING THE NEEDLE STILL INSERTED IN THE PATIENTS HEAD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    640832 DISPOSABLE SCALP NEEDLE ELECTRODES ELECTRODE GXZ ALPINE BIOMED APS 9013R0313 60550

    Patients

    Seq Age Sex Outcome Treatment
    1 Other