BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    E SJ2/FC/ST/150/.035/T

    MDR report key: 568203 · Received January 14, 2005

    Report

    Report Number
    9616099-2005-00670
    Event Type
    Malfunction
    Date Received
    January 14, 2005
    Date of Event
    June 10, 2004
    Report Date
    January 12, 2005
    Manufacturer
    CORDIS DE MEXICO
    Product Code
    DQX
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    A 19 GAUGE NEEDLE WITH AN INTERIOR DIAMETER OF 0.027 WAS USED WITH A 0.035 GUIDEWIRE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 E SJ2/FC/ST/150/.035/T ENDOVASCULAR WIRES & METALS DQX CORDIS DE MEXICO NA N0204117

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN