BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AMBU NEUROLINE CONCENTRIC

    MDR report key: 5070855 · Received September 11, 2015

    Report

    Report Number
    9610691-2015-00005
    Event Type
    Injury
    Date Received
    September 11, 2015
    Report Date
    August 12, 2015
    Manufacturer
    AMBU A/S
    Product Code
    IKT
    PMA / PMN Number
    K071186
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CI
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    WE HAVE REVIEWED THE PRODUCTION RECORDS AND DID NOT FIND ANY ABNORMALITY DURING PRODUCTION. THE REVIEW OF 10 RETENTION SAMPLES INCLUDING THE LOT INVOLVED DO NOT HAVE ANY STRESS MARKS. AT SIMULATION EXPERIMENTS IT HAS BEEN DEMONSTRATED THAT BENDING THE NEEDLE AT ANGLES AROUND 40° AND AROUND 70° WILL NOT CAUSE THE NEEDLE TO BREAK EVEN AFTER 70 OR 30 TIMES OF BENDING IN OPPOSITE DIRECTIONS, RESPECTIVELY. WE CONCLUDE THAT THE LIKELY CAUSE OF THE TIP BROKE OFF IS DUE TO MULTIPLE WIDE ANGLE BENDING. OUR NEEDLES MEET ISO9626:1991 BENDING FORCE REQUIREMENTS,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. DEVICE WAS NOT RETURNED TO MANUFACTURER.

    Description of Event or Problem · 1

    CUSTOMER REPORTED THAT THE NEEDLE HAD COME OFF THE PLASTIC HEAD, LEAVING NEEDLE IN THE PATIENT. THE NEEDLE GOT BROKE AT THE JUNCTION BETWEEN METAL AND PLASTIC HUB. THE PROCEDURE PERFORMED WAS AND EMG IN THE GLUTEUS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    601851 AMBU NEUROLINE CONCENTRIC ELECTROMYOGRAPH ELECTRODE IKT AMBU A/S 74038-45/25 1719434

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR Other