BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TECA ELITE DISPOSABLE CONCENTRIC NEEDLE ELECTR

    MDR report key: 1719581 · Received May 28, 2010

    Report

    Report Number
    2126317-2010-00002
    Event Type
    Malfunction
    Date Received
    May 28, 2010
    Date of Event
    April 26, 2010
    Report Date
    May 26, 2010
    Manufacturer
    CAREFUSION, IRELAND 241 LTD.
    Product Code
    IKT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    FOURTEEN NEEDLE SEPARATIONS REPORTED IN 1.8 MILLION ESTIMATED CONSUMED NEEDLES OR 7.22 X 10-6 REPORTED RATIO OF STICKS TO SEPARATIONS IS 2 IN 14 OR 0.1538. LIKELIHOOD OF SERIOUS INJURY RESULTING FROM A NEEDLE STICK IS 1 IN 10,000 (.0001). LIKELIHOOD OF SERIOUS INJURY = 7.22X10-6 X .0.1538 X 0.0001 = 1.11X10-10. WITH 1.2 MILLION NEEDLES REMAINING TO BE CONSUMED, THE ESTIMATED NEEDLE SEPARATION = 9.33. OF THOSE 9 OR 10 SEPARATIONS, 1 OR 2 COULD RESULT IN A NEEDLE STICK. WITH AN EXTREMELY LOW LIKELIHOOD OF SERIOUS INJURY RESULTING FROM A NEEDLE STICK, IT IS DETERMINED THAT NO FIELD ACTION IS REQUIRED. THE LIKELIHOOD OF SERIOUS INJURY IS REMOTE.

    Description of Event or Problem · 1

    DURING THE ELECTRODE LEAD DISCONNECT PROCESS, WHILE PERFORMING AN EMG PROCEDURE, THE OUTER HUB TO THE NEEDLE ASSEMBLY CAME APART ALLOWING THE NEEDLE ASSEMBLY TO COME OUT OF THE PROTECTIVE SHEATH. WHEN THIS OCCURRED, THE DOCTOR WAS STUCK WITH THE UNPROTECTED USED EMG NEEDLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TECA ELITE DISPOSABLE CONCENTRIC NEEDLE ELECTR ELECTRODE, NEEDLE, DIAGNOSTIC, EMG IKT CAREFUSION, IRELAND 241 LTD. 1.5" LONG 26 GAGE 13A/09/P

    Patients

    Seq Age Sex Outcome Treatment
    1 Other