BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MEW MEDICAL TECHNOLOGY LTD - SAFETY SYRINGE

    MDR report key: 478811 · Received August 12, 2003

    Report

    Report Number
    MW1029306
    Event Type
    Malfunction
    Date Received
    August 12, 2003
    Date of Event
    August 6, 2003
    Report Date
    August 6, 2003
    Manufacturer
    NEW MEDICAL TECHNOLOGY, LTD/ NEW MEDICAL HOUSE
    Product Code
    FMF
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    PHARMACIST

    Narratives

    Description of Event or Problem · 1

    PT REPORTS USING NMT SAFETY SYRINGE 1 CC/ML 276 X 1/2" 0.4 MM X 13 MM, REF 20017, LOT 102078, EXP. 8/2005. THEY REPORT WHEN INJECTING MEDICATION SUBCUTANEOUSLY, THEY NOTICED LEAKAGE OF THE MEDICATION FROM THE SIDE OF THE SYRINGE NEAR THE NEEDLE HUB CONNECTION TO THE SYRINGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MEW MEDICAL TECHNOLOGY LTD - SAFETY SYRINGE SAFETY SYRINGE FMF NEW MEDICAL TECHNOLOGY, LTD/ NEW MEDICAL HOUSE REORDER/REF. 20017 102078

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR Other