BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COOK INC.

    MDR report key: 42706 · Received October 17, 1996

    Report

    Report Number
    42706
    Event Type
    Injury
    Date Received
    October 17, 1996
    Date of Event
    September 9, 1996
    Report Date
    September 20, 1996
    Manufacturer
    COOK INC.
    Product Code
    DYB
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    NC, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    IN AN ATTEMPT TO INSERT A PORT MULTIPLE ATTEMPTS WERE MADE USING CO INTRODUCER SETS. A PORTION OF THE GUIDEWIRE WAS IDENTIFIED BY X-RAY IN THE TISSUE OUTSIDE THE VEIN IN THE SUBCLAVIAN AREA. UNSUCCESSFUL ATTEMPT WAS MADE TO RETRIEVE THE GUIDEWIRE FROM THE TISSUE AREA. PHYSICIAN AND PT ELECTED TO LEAVE GUIDEWIRE IN TISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COOK INC. INTRODUCER SET DYB COOK INC. NA 581257

    Patients

    Seq Age Sex Outcome Treatment
    1 39 YR Hospitalization