BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GROSHONG ATTACHABLE VENOUS CATHETER

    MDR report key: 1010535 · Received February 15, 2008

    Report

    Report Number
    1010535
    Event Type
    Malfunction
    Date Received
    February 15, 2008
    Date of Event
    February 8, 2008
    Report Date
    February 15, 2008
    Manufacturer
    BARD ACCESS SYSTEMS
    Product Code
    LJT
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MT, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    STAFF ENCOUNTERED DIFFICULTY GETTING BLOOD RETURN, AND THE PATIENT REPORTED SOME PAIN WHEN THE GROSHONG WAS FLUSHED. THE PATIENT WAS SENT FOR A RADIOLOGIC INTERVENTION, AND CONTRAST REVEALED THAT THE TIP WAS IN THE SUPRACLAVICULAR SOFT-TISSUE AND A CATHETER FRAGMENT IN THE RIGHT SIDE OF THE HEART. ALL PARTS WERE SUCCESSFULLY REMOVED FROM THE PATIENT. THE CATHETER HAS THE APPEARANCE OF BEING CUT. UNFORTUNATELY THE RADIOLOGIST GAVE A PORTION OF THE CATHETER TO THE PATIENT, AND IT HAS BEEN TOSSED OUT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GROSHONG ATTACHABLE VENOUS CATHETER PORT, IMPLANTED LJT BARD ACCESS SYSTEMS 7707540 RERB0049

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR CHEMOTHERAPY| CHEMOTHERAPY