BEUDAMED
    FDA Adverse Event Death Summary report: N

    FLEXIFLO ENTERAL FEEDING TUBE

    MDR report key: 83484 · Received April 10, 1997

    Report

    Report Number
    1528738-1997-00020
    Event Type
    Death
    Date Received
    April 10, 1997
    Date of Event
    October 1, 1996
    Report Date
    April 10, 1997
    Manufacturer
    ABBOTT MFG., INC.
    Product Code
    BSS
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    AN NG TUBE WAS PLACED IN AN ELDERLY PT DUE TO POOR ORAL INTAKE. THE TUBE WAS PLACED BY A NURSE AND TUBE PLACEMENT WAS VERIFIED BY 3 NURSES USING AUSCULTATION. THE PT WENT INTO CARDIAC ARREST 3 HRS AFTER TUBE PLACEMENT. CPR WAS INITIATED AND 911 WAS CALLED. APPROX 100 CC OF AN ENTERAL FEEDING SOLUTION HAD BEEN INFUSED. THE PT WAS TRANSPORTED TO THE HOSP WHERE A TRACHEOSTOMY WAS PERFORMED AND BILATERAL CHEST TUBES WERE PLACED. THE PT EXPIRED AT APPROX 10:00 PM. AN AUTOPSY WAS PERFORMED AND SHOWED TO PERFORATIONS IN THE LUNGS, ONE ON EACH SIDE. RPTR HAS BEEN UNABLE TO OBTAIN A COPY OF THE AUTOPSY REPORT AS THE CASE IS IN LITIGATION, THUS IT IS NOT POSSIBLE TO DETERMINE WHERE THE PERFORATIONS WERE LOCATED OR HOW THEY WERE MADE. ONE PT INVOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FLEXIFLO ENTERAL FEEDING TUBE 78 BSS TUBE, NASOGASTRIC BSS ABBOTT MFG., INC. 477 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Death NONE REPORTED