BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    JELCO HYPODERMIC NEEDLE PRO EDGE SAFETY DEVICE

    MDR report key: 1872135 · Received October 11, 2010

    Report

    Report Number
    2183502-2010-00444
    Event Type
    Malfunction
    Date Received
    October 11, 2010
    Date of Event
    September 9, 2010
    Report Date
    October 8, 2010
    Manufacturer
    SMITHS MEDICAL ASD, INC.
    Product Code
    FMI
    PMA / PMN Number
    K041399
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CUSTOMER HAS NOT YET RETURNED THE DEVICE TO THE MANUFACTURER FOR DEVICE EVALUATION. WHEN AND IF THE DEVICE BECOMES AVAILABLE AND IS RETURNED AND EVALUATED THE MANUFACTURER WILL FILE A F/U REPORT DETAILING THE RESULTS OF THE EVALUATION.

    Description of Event or Problem · 1

    A REPORT WAS REC'D THAT STATED THAT THE CANNULA OF THE NEEDLE WAS BENT, IT WAS NOT FULLY CAPTURED IN THE SAFETY DEVICE AND WAS EXPOSED. NO NEEDLESTICK TOOK PLACE. THERE WAS NO PT OR CLINICIAN INJURY. THE DEVICE WAS DISCARDED AND IS NOT AVAILABLE FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 JELCO HYPODERMIC NEEDLE PRO EDGE SAFETY DEVICE FMI - NEEDLE, HYPODERMIC, SINGLE LUMEN FMI SMITHS MEDICAL ASD, INC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK