BEUDAMED
    FDA Adverse Event Other Summary report: N

    MICROPUNCTURE INTRODUCER SET

    MDR report key: 384391 · Received March 25, 2002

    Report

    Report Number
    384391
    Event Type
    Other
    Date Received
    March 25, 2002
    Date of Event
    December 20, 2001
    Report Date
    February 26, 2002
    Manufacturer
    COOK INCORPORATED
    Product Code
    DYB
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    AR, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    WHILE ATTEMPTING A TEMPORARY DIALYSIS CATHETER PLACEMENT, A GUIDEWIRE LODGED AND BROKE, LEAVING A TINY PORTION OF WIRE IN LEFT INTERNAL JUGULAR VEIN. THIS WAS CONFIRMED BY ULTRASOUND AND X-RAY. THERE WAS NO ATTEMPT TO REMOVE SURGICALLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MICROPUNCTURE INTRODUCER SET SPECIAL SET DYB COOK INCORPORATED NA 1106184

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Other