BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AMBU NEUROLINE CONCENTRIC NEEDLE

    MDR report key: 2070291 · Received April 19, 2011

    Report

    Report Number
    9610691-2011-00002
    Event Type
    Injury
    Date Received
    April 19, 2011
    Date of Event
    March 18, 2011
    Report Date
    April 19, 2011
    Manufacturer
    AMBU A/S
    Product Code
    IKT
    PMA / PMN Number
    K071186
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    AT STIMULATION EXPERIMENTS, IT HAS BEEN DEMONSTRATED THAT BENDING THE NEEDLE AT ANGLES AROUND 45 DEGREES WILL NOT CAUSE THE NEEDLE TO BREAK EVEN AFTER 50 TIMES OF BENDING IN OPPOSITE DIRECTIONS. WE CONCLUDE THAT THE CAUSE OF THE TIP BROKE OFF MIGHT BE DUE TO MULTIPLE WIDE ANGLE BENDING. ALTHOUGH OUR NEEDLES MEET (B)(4) BENDING FORCE REQUIREMENTS, THEY CAN BREAK OFF IF THEY ARE BENT AT WIDE ANGLE MULTIPLE TIMES. DURING NORMAL USAGE, THERE IS NO DANGER THAT THE NEEDLE WILL BREAK BECAUSE THEY ARE DESIGNED TO WITHSTAND MANY TIMES OF BENDING WITHIN THE FLEXIBLE LIMIT.

    Description of Event or Problem · 1

    AN (B)(6) UNDERWENT EMG. DURING PROCEDURE IN LEFT HIP, THE NEEDLE BROKE OFF FROM THE HUB AND WAS RETAINED IN THE PATIENT. PATIENT 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 PATIENT ACCORDINGLY. THE MEDWATCH REPORT FROM HOSPITAL DOES NOT INCLUDE THE FOLLOWING, BUT IT WAS TOLD TO THE AMBU INC REPRESENTATIVE BY THE RISK MANAGER (HER INFORMATION IS BELOW): DR (B)(6) WAS DOING A LEFT HIP EMG ON AN (B)(6) PATIENT. HE INSERTED THE NEEDLE AND IT STARTED TO BEND. HE REMOVED IT, REPOSITIONED IT, THEN REINSERTED IT. IT BEGAN TO BEND AGAIN AND THEN BROKE. THE NEEDLE LENGTH SELECTED BY THE NEUROLOGIST IS THE SHORTEST NEEDLE AVAILABLE IN THIS SERIES. NEEDLE DIMENSIONS ARE LENGTH: 25MM/1 INCH; CALIBER 0.30 MM/30 GAUGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AMBU NEUROLINE CONCENTRIC NEEDLE SINGLE PATIENT EMG NEEDLE IKT AMBU A/S AMBU NEUROLINE CON 1112729

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Other