BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HYPODERMIC NEEDLE-PRO WITH NEEDLE PROTECTION DEVICE

    MDR report key: 4232334 · Received October 23, 2014

    Report

    Report Number
    2183502-2014-00795
    Event Type
    Malfunction
    Date Received
    October 23, 2014
    Date of Event
    October 1, 2014
    Report Date
    October 23, 2014
    Manufacturer
    SMITHS MEDICAL INC.
    Product Code
    FMJ
    PMA / PMN Number
    K923127
    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 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 DURING AN INJECTION, THE NEEDLE BECAME DETACHED FROM THE SYRINGE AND REMAINED IN THE PATIENT'S ARM. THE CLINICIAN WAS ABLE TO RETRIEVE THE NEEDLE BY HAND. NO NEEDLE-STICK TOOK PLACE. THERE WAS NO PATIENT OR CLINICIAN INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    674410 HYPODERMIC NEEDLE-PRO WITH NEEDLE PROTECTION DEVICE FMJ - NEEDLE, HYPODERMIC FMJ SMITHS MEDICAL INC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK