BEUDAMED
    FDA Adverse Event Injury Summary report: N

    JELCO NEEDLE-PRO EDGE NEEDLE

    MDR report key: 1772168 · Received July 23, 2010

    Report

    Report Number
    2183502-2010-00311
    Event Type
    Injury
    Date Received
    July 23, 2010
    Date of Event
    June 21, 2010
    Report Date
    July 19, 2010
    Manufacturer
    SMITHS MEDICAL ASD, INC.
    Product Code
    FMI
    PMA / PMN Number
    K011925
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    NURSE

    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 A NURSE RECEIVED A NEEDLE STICK. THE REPORT STATED THAT THE NEEDLE CAME DETACHED FROM THE SYRINGE BECAME EXPOSED AFTER IF HAD BEEN USED. THE NURSE WAS STUCK BY A PROTRUDING PART OF THE NEEDLE. THERE WAS NO REPORT OF INCIDENT RELATED MEDICAL SEQUELAE AND NO TREATMENT WAS REPORTED. THE DEVICE WAS DISCARDED AND IS NOT AVAILABLE FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 JELCO NEEDLE-PRO EDGE NEEDLE FMI - NEEDLE, HYPODERMIC, SINGLE LUMEN FMI SMITHS MEDICAL ASD, INC. NA 1747835

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention