BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERCUTANEOUS ENTRY NEEDLE

    MDR report key: 377782 · Received February 22, 2002

    Report

    Report Number
    1820334-2002-00020
    Event Type
    Injury
    Date Received
    February 22, 2002
    Date of Event
    January 23, 2002
    Report Date
    January 23, 2002
    Manufacturer
    COOK, INC.
    Product Code
    DWO
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    DURING AN ANGIOPLASTY, UPON THE INTRODUCTION OF THE NEEDLE INTO THE VEIN, THERE WAS A LACK OF BLOOD RETURN. AFTER PUNCTURING THE VESSEL THREE TO FOUR TIMES, THE PHYSICIAN EVENTUALLY PULLED THE NEEDLE OUT OF THE VESSEL WALL AND WIRED THE NEEDLE LUMEN. FROM INSIDE THE NEEDLE LUMEN CAME A LONG CYLINDER PIECE OF PLASTIC PLUG, PERFECTLY CONFORMED TO THE NEEDLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PERCUTANEOUS ENTRY NEEDLE NEEDLE DWO COOK, INC. NA 1106075

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Required Intervention