BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HYPODERMIC NEEDLE PRO INSULIN SYRINGE W/EDGE SAFETY DEVICE

    MDR report key: 3881187 · Received February 10, 2014

    Report

    Report Number
    2183502-2014-00021
    Event Type
    Malfunction
    Date Received
    February 10, 2014
    Date of Event
    January 13, 2014
    Report Date
    February 10, 2014
    Manufacturer
    SMITHS MEDICAL INC
    Product Code
    FMF
    PMA / PMN Number
    K014073
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    RISK MANAGER

    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. THERE WAS NO PATIENT OR CLINICIAN INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    88076 HYPODERMIC NEEDLE PRO INSULIN SYRINGE W/EDGE SAFETY DEVICE FMF-SYRINGE FMF SMITHS MEDICAL INC NA 2578487

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK