BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FLEXIFLO ENTERAL FEEDING TUBE

    MDR report key: 516770 · Received March 19, 2004

    Report

    Report Number
    1528738-2004-00008
    Event Type
    Injury
    Date Received
    March 19, 2004
    Date of Event
    February 18, 2004
    Report Date
    February 18, 2004
    Manufacturer
    ROSS PRODUCTS DIV., ABBOTT LABORATORIES
    Product Code
    BSS
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    HEALTHCARE PROFESSIONAL ATTEMPTED TO PLACE THE DEVICE BUT WOULD NOT GO "ALL THE WAY DOWN." SEVERAL ATTEMPTS WERE MADE, BUT THE DEVICE WOULD NOT PASS INTO THE STOMACH AS SEEN ON X-RAY. WHEN THE DEVICE WAS REMOVED, THE GUIDEWIRE WAS STICKING THROUGH THE TUBE NEAR THE WEIGHTED END. NURSING STAFF WAS CONCERNED THAT THE GUIDEWIRE WAS STICKING INTO THE PT AND THAT WAS WHY IT WASN'T GOING DOWN. THE GUIDEWIRE HAD NOT BEEN PROTRUDING PRIOR TO INSERTION. A FEW DAYS LATER, ANOTHER ATTEMPT WAS MADE TO PLACE THE DEVICE, BUT THE PT BEGAN COUGHING UP BLOOD. THE PROCEDURE WAS STOPPED AND A PEG TUBE WAS INSERTED. NURSING STAFF WAS UNSURE IF THE PRIOR EVENT CAUSED ANY DAMAGE THAT MIGHT HAVE RESULTED IN HEMATEMESIS. THE PT HAS RECOVERED WELL AND WAS DISCHARGED TO A NURSING HOME. ONE PT INVOLVED. NOTE: THE EVENT DATE GIVEN ABOVE IS APPROXIMATE.

    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 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Required Intervention