BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NMT SAFETY SYRINGE

    MDR report key: 489376 · Received September 25, 2003

    Report

    Report Number
    MW1029666
    Event Type
    Malfunction
    Date Received
    September 25, 2003
    Report Date
    September 25, 2003
    Manufacturer
    NEW MEDICAL TECHNOLOGY, INC.
    Product Code
    FMF
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MN, US
    Reporter Occupation
    PHARMACIST

    Narratives

    Description of Event or Problem · 1

    SYRINGE/NEEDLE UNIT LEAKED AROUND HUB DURING INJECTION -2X REPORTED- NEEDLE FAILED TO RETRACT -1X- REPORTED. ALL STAFF -NURSING- TRAINED IN PROPER USE. PRODUCT SUPPLIED IN KIT FORM WITH FUZEON -ROCHE LABS-

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NMT SAFETY SYRINGE SYRINGE WITH RETRACTABLE NEEDLE FMF NEW MEDICAL TECHNOLOGY, INC. * 102009

    Patients

    Seq Age Sex Outcome Treatment
    1 *