BEUDAMED
    FDA Adverse Event Death Summary report: N

    FLEXIFLO ENTERAL FEEDING TUBE

    MDR report key: 328085 · Received April 19, 2001

    Report

    Report Number
    1528738-2001-00020
    Event Type
    Death
    Date Received
    April 19, 2001
    Date of Event
    February 22, 2001
    Report Date
    March 20, 2001
    Manufacturer
    ROSS PRODUCTS DIVISION/ABBOTT LABORATORIES
    Product Code
    BSS
    Report Source
    Manufacturer report

    Narratives

    Description of Event or Problem · 1

    PT HAD AN NG TUBE IN PLACE. ENTERAL FEEDING TUBE WAS PLACED AND X-RAY DONE TO CONFIRM PLACEMENT. THE NG TUBE WAS LATER REMOVED AND FEEDING WAS INITIATED VIA THE ET TUBE. PT BEGAN TO SHOW SIGNS OF RESPIRATORY DISTRESS. REPEAT X-RAY SHOWED ET TUBE IN THE LUNG. ET TUBE WAS REMOVED AND EMERGENCY BRONCHOSCOPY PERFORMED. PT WAS HYPOXIC AND SEVERELY CONGESTED. PT EXPIRED 3 DAYS LATER. REPORTER CONFIRMED THERE WAS NOTHING WRONG WITH THE DEVICE. IT WAS USER ERROR READING THE X-RAY. ONE PT INVOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    17961 FLEXIFLO ENTERAL FEEDING TUBE 78 BSS TUBE, NASOGASTRIC BSS ROSS PRODUCTS DIVISION/ABBOTT LABORATORIES 473 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1