BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    JELCO NEEDLE-PRO NEEDLE

    MDR report key: 2140328 · Received June 17, 2011

    Report

    Report Number
    2183502-2011-00487
    Event Type
    Malfunction
    Date Received
    June 17, 2011
    Date of Event
    May 19, 2011
    Report Date
    June 16, 2011
    Manufacturer
    SMITHS MEDICAL ASD, INC.
    Product Code
    FMI
    PMA / PMN Number
    K923127
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT STATED THAT AT THE CONCLUSION OF AN INJECTION, THE CANNULA OF THE NEEDLE 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 EVAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 JELCO NEEDLE-PRO NEEDLE FMI - NEEDLE, HYPODERMIC, SINGLE LUMEN FMI SMITHS MEDICAL ASD, INC. NA 1698770

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK