BEUDAMED
    FDA Adverse Event Death Summary report: N

    FLEXIFLO ENTERAL FEEDING TUBE

    MDR report key: 68304 · Received February 7, 1997

    Report

    Report Number
    1528738-1997-00007
    Event Type
    Death
    Date Received
    February 7, 1997
    Date of Event
    December 4, 1996
    Report Date
    February 6, 1997
    Manufacturer
    ROSS PRODUCTS DIV. ABBOTT LABORATORIES
    Product Code
    BSS
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE DEVICE WAS PLACED, BUT A KUB WAS NOT DONE TO CONFIRM PLACEMENT. FOUR TO SIX HRS LATER THE PT CODED, AND MAY HAVE ASPIRATED STOMACH CONTENTS. A CHEST X-RAY SHOWED THE FEEDING TUBE IN THE LEFT LUNG. THE FEEDING TUBE PLACEMENT HAD BEEN VERIFIED BY AUSCULTATION ONLY. THE PT EXPIRED. NOTHING HAD BEEN FED THROUGH THE FEEDING TUBE. THE CAUSE OF DEATH WAS ASPIRATION. THERE HAD BEEN NO COMPLICATIONS IMMEDIATELY FOLLOWING THE INTUBATION OF THE LUNG. ONE PT INVOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FLEXIFLO ENTERAL FEEDING TUBE Implant 78 BSS TUBE, NASOGASTRIC BSS ROSS PRODUCTS DIV. ABBOTT LABORATORIES 475 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR Death NONE REPORTED