BEUDAMED
    FDA Adverse Event Other Summary report: N

    PORTEX

    MDR report key: 1415053 · Received July 16, 2009

    Report

    Report Number
    MW5011972
    Event Type
    Other
    Date Received
    July 16, 2009
    Date of Event
    July 6, 2009
    Report Date
    July 6, 2009
    Manufacturer
    SMITHS MEDICAL ASD, INC.
    Product Code
    FMI
    Report Source
    Voluntary report
    Reporter Location
    SC, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    NURSE WAS APPLYING A CLEAN PORTEX HYPODERMIC NEEDLE PRO NEEDLE WITH NEEDLE PROTECTIVE DEVICE 23G X 1" EXP. 2013-02 TO A UNIT DOSE SYRINGE. AS SHE TWISTED THE CAPPED NEEDLE ONTO THE VACCINE SYRINGE. SHE NOTED TO BE STUCK BY THE CAPPED NEEDLE THE NEEDLE WAS PROTRUDING THROUGH THE CAP - AN APPARENT DEFECT FROM THE MANUFACTURER, CLEAN NEEDLE STICK INJURY TO NURSE'S MIDDLE FINGER RIGHT HAND.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PORTEX HYPODERMIC NEEDLE PRO FMI SMITHS MEDICAL ASD, INC. 1286076

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR Other