BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BARD

    MDR report key: 5124840 · Received May 25, 2004

    Report

    Report Number
    5124840
    Event Type
    Injury
    Date Received
    May 25, 2004
    Date of Event
    May 18, 2004
    Report Date
    May 24, 2004
    Manufacturer
    BAND ENDOSCOPIC TECHNOLOGIES C.B.BARD. INC.
    Product Code
    NKQ
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    PATIENT WAS UNDERGOING ON EGD WITH DILATION. ONCE DILATION WAS COMPLETE, DILATOR AND GUIDEWIRE WERE REMOVED. AT THAT TIME, IT WAS OBSERVED THAT THE SPRING TIP OF THE GUIDE WIRE WAS NO LONGER ATTACHED. THE GASTROSCOPE WAS INSERTED IN AN ATTEMPT TO RETRIEVE THE SPRING TIP. DURING THIS TIME, THE PATIENT BECAME AGITATED AND CONFUSED, PULLED AT THE SCOPE, SET UP GRASPING AT HER NECK STATING "I CAN'T BREATH". RESUSCITATION STEPS IMMEDIATELY INITIATED. MFR# 1223688-2004-00033.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BARD MARKED SPRING TIP GUIDEWIRE NKQ BAND ENDOSCOPIC TECHNOLOGIES C.B.BARD. INC. 22C02369

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Hospitalization| L