BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VASONOVA VPS

    MDR report key: 1496620 · Received October 8, 2009

    Report

    Report Number
    3006795936-2009-00001
    Event Type
    Injury
    Date Received
    October 8, 2009
    Date of Event
    July 31, 2009
    Report Date
    October 5, 2009
    Manufacturer
    VASONOVA INC.
    Product Code
    LJS
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE NERVE INJURY WAS CAUSED BY INSERTION OF THE NEEDLE WHICH IS A PART OF THE VASONOVA POWER INJECTABLE PICC LINE INSERTION KIT. THE NEEDLE IS MADE BY MARTECH (SUPER SHARP, 21GX2-3/4IN, ECHOGENIC TIP, GREEN, NS).

    Description of Event or Problem · 1

    PATIENT STATED THAT HE HAS SUFFERED NUMBNESS IN HIS RIGHT HAND.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VASONOVA VPS POWER INJECTABLE PICC LINE INSERTION KIT LJS VASONOVA INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Disability