BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    JELCO HYPODERMIC NEEDLE-PRO SAFETY DEVICE

    MDR report key: 3063080 · Received February 19, 2013

    Report

    Report Number
    2183502-2013-00037
    Event Type
    Malfunction
    Date Received
    February 19, 2013
    Report Date
    February 15, 2013
    Manufacturer
    SMITHS MEDICAL ASD, INC.
    Product Code
    FMI
    PMA / PMN Number
    K011925
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    UNKNOWN

    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 FOLLOW-UP REPORT DETAILING THE RESULTS OF THE EVALUATION.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT STATED THAT 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 EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    72271 JELCO HYPODERMIC NEEDLE-PRO SAFETY DEVICE FMI - NEEDLE, HYPODERMIC, SINGLE LUMEN FMI SMITHS MEDICAL ASD, INC. NA 2065320

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK