BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NMT SAFETY SYRINGE

    MDR report key: 439350 · Received January 23, 2003

    Report

    Report Number
    MW1027317
    Event Type
    Malfunction
    Date Received
    January 23, 2003
    Date of Event
    January 15, 2003
    Report Date
    January 17, 2003
    Manufacturer
    NEW MEDICAL TECHNOLOGY, INC.
    Product Code
    FMF
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MA, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    WHILE THE NURSE WAS ADMINISTERING MEDICATION INTRAMUSCULARLY WITH THE LISTED SYRINGE THE NEEDLE PREMATURELY RETRACTED INTO THE BARREL OF THE SYRINGE. THE MEDICATION ADMINISTRATION HAD TO BE STOPPED AND A NEW SYRINGE AND MEDICATION USED AT A DIFFERENT INJECTION SITE. ALSO, DUE TO THE SYRINGE HAVING MORE THAN 0.5ML OF MEDICATION REMAINING IN THE BARREL, THE NEEDLE WOULD NOT FULLY RETRACT INTO THE BARREL AS DESIGNED PRESENTING A POTENTIAL NEEDLE STICK HAZARD. MEDICATION BEING INJECTED WAS FLUPHENAZINE DECANOATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NMT SAFETY SYRINGE SYRINGE FMF NEW MEDICAL TECHNOLOGY, INC. 3CC 21G X 1 1/2" 101046

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Other