BEUDAMED
    FDA Adverse Event Summary report: N

    VENOUS WINDOW NEEDLE GUIDE

    MDR report key: 3150446 · Received March 7, 2013

    Report

    Report Number
    3150446
    Date Received
    March 7, 2013
    Date of Event
    February 27, 2013
    Report Date
    February 27, 2013
    Manufacturer
    VITAL ACCESS CORP.
    Product Code
    KNW
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    PATIENT WAS PART OF A CLINICAL TRIAL OF INVESTIGATIONAL DEVICE TO FACILITATE CANNULATION OF ARTERIOR-VENOUS FISTULAS. UPON THE PATIENT'S 3 MONTH FOLLOW UP VISIT, INVESTIGATOR'S LEARNED THAT CANNULATING THE DEVICE CAUSED PAIN. THE DEVICE WAS FOUND TO HAVE TILTED, AND PATIENT REQUESTED ITS REMOVAL. IT WAS REMOVED (B)(6) 2013.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    98631 VENOUS WINDOW NEEDLE GUIDE KNW VITAL ACCESS CORP. 00170 11-0100

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR