BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NEUROLINE CONCENTRIC SINGLE PATIENT NEEDLE

    MDR report key: 2030539 · Received March 21, 2011

    Report

    Report Number
    MW5019913
    Event Type
    Injury
    Date Received
    March 21, 2011
    Date of Event
    March 18, 2011
    Report Date
    March 21, 2011
    Manufacturer
    AMBU, INC.
    Product Code
    IKT
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MI, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    AN (B)(6) FEMALE UNDERWENT EMG. DURING PROCEDURE IN LEFT HIP, THE NEEDLE BROKE OFF FROM THE HUB AND WAS RETAINED IN THE PT. PT TAKEN TO ER FOR ATTEMPTED REMOVAL. ER PHYSICIAN DETERMINED THAT BASED ON LOCATION OF NEEDLE ON X-RAY, DEEP INSIDE TISSUE, IT MAY CAUSE MORE HARM TO REMOVE IT, SO HE DECIDED TO LEAVE NEEDLE IN. HE ADVISED NEUROLOGIST AND PT ACCORDINGLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NEUROLINE CONCENTRIC SINGLE PATIENT NEEDLE NEEDLE IKT AMBU, INC. 74025-30/25 1112729

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Other