BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FASTRAC GASTRIC ACCESS PORT SAFETY SYSTEM

    MDR report key: 1202336 · Received October 15, 2008

    Report

    Report Number
    MW5008643
    Event Type
    Injury
    Date Received
    October 15, 2008
    Date of Event
    October 14, 2008
    Report Date
    October 15, 2008
    Manufacturer
    BARD ACCESS SYSTEMS, INC.
    Product Code
    KNT
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    KS, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    EGD WAS GASTROSTOMY TUBE PLACEMENT WITH BARD GASTRIC ACCESS PORT SAFETY SYSTEM, WHILE USING THE SNARE, THE WIRE CAME OUT OF THE SNARE. STAFF WAS UNAWARE INITIALLY THE WIRE CAME COMPLETELY OUT OF THE SNARE AND WAS IN PATIENT'S THROAT. THE PHYSICIAN TOOK ANOTHER LOOK AFTER COMPLETING THE PROCEDURE AND FOUND WIRE IN THROAT AND REMOVED IT. X-RAY TAKEN TO VERIFY ALL WAS REMOVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FASTRAC GASTRIC ACCESS PORT SAFETY SYSTEM PEG FEEDING TUBE KNT BARD ACCESS SYSTEMS, INC. 007023 HUSD0381

    Patients

    Seq Age Sex Outcome Treatment
    1 Disability