BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HYPODERMIC NEEDLE-PRO AND NEEDLE WITH NEEDLE PROTECTION DEVICE

    MDR report key: 2632647 · Received June 22, 2012

    Report

    Report Number
    2183502-2012-00265
    Event Type
    Malfunction
    Date Received
    June 22, 2012
    Date of Event
    May 23, 2012
    Report Date
    June 22, 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

    DEVICE HAS BEEN RETURNED FOR EVALUATION. ONCE THE DEVICE HAS BEEN 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 DURING AN INJECTION VIA A GLUTEAL NEEDLE THE NEEDLE BECAME DETACHED FROM THE SYRINGE AND REMAINED IN THE PATIENT. THE NURSE REMOVED THE DETACHED NEEDLE FROM THE PATIENT. NO NEEDLESTICK TOOK PLACE. THERE WAS NO PATIENT 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