BEUDAMED
    FDA Adverse Event Death Summary report: N

    FLEXIFLO ENTERAL FEEDING TUBE

    MDR report key: 47552 · Received November 5, 1996

    Report

    Report Number
    1528738-1996-00025
    Event Type
    Death
    Date Received
    November 5, 1996
    Date of Event
    July 27, 1996
    Report Date
    November 5, 1996
    Manufacturer
    ROSS PRODUCTS DIV. ABBOTT LABORATORIES
    Product Code
    BSS
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    ON 7/27/96, THE PT'S FEEDING TUBE WAS FOUND CONNECTED TO THE OXYGEN TUBING FOR HIS NASAL CANNULA. THE PT'S ABDOMEN WAS DISTENDED AND HE COMPLAINED OF PAIN. A SHORT TIME LATER, THE PT BECAME UNRESPONSIVE, WAS CODED AND TRANSFERRED TO ICU. X-RAYS CONFIRMED FREE AIR IN THE ABDOMEN AND A PERFORATION OF THE COLON, SUBSEQUENTLY, A COLOSTOMY AND A GASTROSTOMY TUBE WERE PLACED. THE PT DEVELOPED SEPSIS AND HIS CONDITION DETERIORATED. THE PT EXPIRED ON 8/20/96. THE REPORTER WAS UNSURE HOW THE CONNECTION BETWEEN THE NG TUBE AND THE OXYGEN TUBING WAS MADE, ALTHOUGH THEY SUSPECT THE PT (WHO WAS DISORIENTED) MAY HAVE PULLED THE NG TUBE OUT, TRIED TO RECONNECT IT, AND CONNECTED IT INCORRECTLY. THE PHYSICIANS ARE UNSURE IF THE AMOUNT OF AIR THAT WAS PUT INTO THE PT COULD HAVE CAUSED THE COLON TO PERFORATE. ONE PT INVOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FLEXIFLO ENTERAL FEEDING TUBE 78 BSS TUBE, NASOGASTRIC BSS ROSS PRODUCTS DIV. ABBOTT LABORATORIES 473 NOT REPORTED

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Death OXYGEN TUBING.