BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HYPODERMIC NEEDLE-PRO® WITH NEEDLE PROTECTION DEVICE

    MDR report key: 5150873 · Received October 14, 2015

    Report

    Report Number
    2183502-2015-00770
    Event Type
    Malfunction
    Date Received
    October 14, 2015
    Report Date
    October 14, 2015
    Manufacturer
    SMITHS MEDICAL
    Product Code
    FMI
    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 STATING THAT DURING AN INJECTION, THE NEEDLE DETACHED FROM THE SYRINGE. NO NEEDLE-STICK TOOK PLACE. NO PATIENT OR CLINICIAN INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    678540 HYPODERMIC NEEDLE-PRO® WITH NEEDLE PROTECTION DEVICE NEEDLE, HYPODERMIC FMI SMITHS MEDICAL NA ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1