BEUDAMED
    FDA Adverse Event Other Summary report: N

    BARDPORT

    MDR report key: 32696 · Received March 1, 1996

    Report

    Report Number
    32696
    Event Type
    Other
    Date Received
    March 1, 1996
    Date of Event
    November 10, 1995
    Report Date
    November 24, 1995
    Manufacturer
    BARD ACCESS SYSTEMS, INC.
    Product Code
    LJT
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    WI, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    DURING THE INSERTION OF AN IMPLANTED PORT BY DR, THE DR COULD NOT REMOVE THE GUIDE WIRE FROM THE PT'S RIGHT SUBCLAVIAN VEIN. HE OBSERVED THE WIRE TO BE "STRIPPED" OR UNRAVELED AND COILED IN THE RIGHT SUBCLAVIAN VEIN. THIS WAS A GUIDE WIRE FROM THE IMPLANTED PORT. THORACIC-CARDIOVASCULAR SURGEON WAS CALLED IN AS A CONSULTANT. THE WIRE WAS LEFT IN THE RIGHT SUBCLAVIAN VEIN. IT WAS LOOPED AND SUTURED IN PLACE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BARDPORT OPEN-ENDED SINGLE LUMEN VENOUS CATHETER, 9.6FR LJT BARD ACCESS SYSTEMS, INC. 36FF7557

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Other