BEUDAMED
    FDA Adverse Event Death Summary report: N

    DAVOL-BARD

    MDR report key: 10303 · Received October 26, 1993

    Report

    Report Number
    10303
    Event Type
    Death
    Date Received
    October 26, 1993
    Date of Event
    October 8, 1993
    Report Date
    October 25, 1993
    Manufacturer
    BARD ACCESS SYSTEMS, INC.
    Product Code
    DQO
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    IN, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    AT 7:30 AM, DISTAL PORT OF CENTRAL LINE WAS FOUND ON FLOOR WITH APPROX 30 CC OF HYPERALIMENTATION SOLUTION. CLAMPED CENTRAL LINE WITH A HEMASTAT ADJACENT TO PT'S NECK. NO BLOOD FROM LINE NOTED. LINE PULLED PER MD ORDER. DRESSING AND PRESSURE APPLIED FOR 10 MINS. APPROX 40 MINS LATER, PT COMPLAINED OF NAUSEA AND SHORTNESS OF BREATH. PT EXPIRED 5:30 PM. IT IS THOUGHT PT MAY HAVE SEVERED CATHETER WITH HIS TEETH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DAVOL-BARD Implant HOHN 7 FRENCH DUAL LUMEN CENTRAL VENOUS CATHETER DQO BARD ACCESS SYSTEMS, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 38 YR Death