BEUDAMED
    FDA Adverse Event Other Summary report: N

    SAFE STEP HUBER NEEDLE SET

    MDR report key: 771331 · Received October 19, 2006

    Report

    Report Number
    MW1040729
    Event Type
    Other
    Date Received
    October 19, 2006
    Date of Event
    October 5, 2006
    Report Date
    October 9, 2006
    Manufacturer
    MDC RESEARCH LTD., MED-DESIGN CORP
    Product Code
    FMI
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    OK, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    PT CALLED TO STATE "MY SHIRT IS WET." ADVISED PT HOW TO TURN OFF PUMP AND CAME INTO OFFICE TO DISCONNECT, WHEN FLUSHING PORT SAW NS LEAKING FROM HUBER NEEDLE SITE. DEACCESSED NEEDLE, DEVICE INTACT. NO SIGNS/SYMPTOMS OF REDNESS OR DRAINAGE AT SITE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SAFE STEP HUBER NEEDLE SET SAFETY HUBER 1" FMI MDC RESEARCH LTD., MED-DESIGN CORP * D612912
    2 SAFE STEP HUBER NEEDLE SET SAFETY HUBER 3/4" FMI MDC RESEARCH LTD, MED-DESIGN CORP * D604331(3/4)
    3 SAFE STEP HUBER NEEDLE SET SAFETY HUBER FMI MDC RESEARCH LTD, MED-DESIGN CORP * D07211

    Patients

    Seq Age Sex Outcome Treatment
    1 * Other