BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HYPODERMIC NEEDLE-PRO NEEDLE WITH PROTECTION DEVICE

    MDR report key: 4201059 · Received September 16, 2014

    Report

    Report Number
    2183502-2014-00685
    Event Type
    Malfunction
    Date Received
    September 16, 2014
    Report Date
    September 15, 2014
    Manufacturer
    SMITHS MEDICAL INC
    Product Code
    FMJ
    PMA / PMN Number
    K011925
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    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. NO NEEDLE-STICK TOOK PLACE. THERE WAS NO PATIENT OR CLINICIAN INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    572406 HYPODERMIC NEEDLE-PRO NEEDLE WITH PROTECTION DEVICE FMJ-HYPODERMIC NEEDLE FMJ SMITHS MEDICAL INC NA 1656729

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK