BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HYPODERMIC NEEDLE-PRO AND NEEDLE WITH NEEDLE PROTECTION DEVICE

    MDR report key: 2622335 · Received June 7, 2012

    Report

    Report Number
    2183502-2012-00225
    Event Type
    Malfunction
    Date Received
    June 7, 2012
    Date of Event
    May 4, 2012
    Report Date
    June 5, 2012
    Manufacturer
    SMITHS MEDICAL ASD, INC.
    Product Code
    FMJ
    PMA / PMN Number
    K965017
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER

    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 DURING AN INJECTION VIA A DELTOID NEEDLE, THE NEEDLE BECAME DETACHED FROM THE SYRINGE AND REMAINED IN THE PT. THE NURSE REMOVED THE DETACHED NEEDLE. NO NEEDLESTICK TOOK PLACE. THERE WAS NO PT OR CLINICIAN INJURY.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK