BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HYPODERMIC NEEDLE-PRO AND NEEDLE WITH NEEDL PROTECTION DEVICE

    MDR report key: 3221309 · Received July 1, 2013

    Report

    Report Number
    2183502-2013-00354
    Event Type
    Malfunction
    Date Received
    July 1, 2013
    Report Date
    June 27, 2013
    Manufacturer
    SMITHS MEDICAL ASD, INC.
    Product Code
    FMJ
    PMA / PMN Number
    K923127
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, 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 FOLLOW-UP REPORT DETAILING THE RESULTS OF THE EVALUATION.

    Description of Event or Problem · 1

    A REPORT WAS FORWARDED FORM THE DISTRIBUTOR: ACCORDING TO THE USER FACILITY, THE NEEDLE BECAME DETACHED FROM THE SYRINGE AND REMAINED IN THE PT. THE NURSE REMOVED THE DETACHED NEEDLE FROM THE PT. NO NEEDLESTICK INJURY WAS REPORTED, NOR WAS PT OR CLINICIAN INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    297308 HYPODERMIC NEEDLE-PRO AND NEEDLE WITH NEEDL PROTECTION DEVICE FMJ - NEEDLE, HYPODERMIC FMJ SMITHS MEDICAL ASD, INC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK