BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HYPODERMIC NEEDLE-PRO AND NEEDLE WITH NEEDLE PROTECTION DEVICE

    MDR report key: 2588839 · Received May 16, 2012

    Report

    Report Number
    2183502-2012-00185
    Event Type
    Malfunction
    Date Received
    May 16, 2012
    Date of Event
    February 17, 2012
    Report Date
    May 7, 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

    THE SUSPECT DEVICE WAS RETURNED AND EVALUATED. INVESTIGATION DETERMINED THAT THE RETURNED SAMPLE MET MFG AND DIMENSIONAL REQUIREMENTS FOR THIS PRODUCT. THE DEVICE PASSED FUNCTIONAL TESTING.

    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 FROM THE PT VIA A GLOVED HAND. 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