BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FLEXIFLO ENTERAL FEEDING TUBE

    MDR report key: 499454 · Received December 1, 2003

    Report

    Report Number
    1528738-2003-00041
    Event Type
    Injury
    Date Received
    December 1, 2003
    Date of Event
    October 24, 2003
    Report Date
    November 5, 2003
    Manufacturer
    ROSS PRODUCTS DIVISION ABBOTT LABORATORIES
    Product Code
    BSS
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    THE DEVICE HAD BEEN IN PLACE 2 DAYS. TUBE BECAME OBSTRUCTED. PHYSICIAN DECIDED TO CHANGE THE TUBE. "AS THE PHYSICIAN DOESN'T THINK THE TUBE REACHED THE STOMACH, SHE DECIDED TO PULL IT OUT, BUT THE TUNGSTEN WEIGHTED TIP STAYED INSIDE THE PT'S BODY." PT RECEIVED AN X-RAY AND ENDOSCOPY IN AN UNSUCCESSFUL ATTEMPT TO FIND THE TUNGSTEN TIP. BRONCHOSCOPY WAS PERFORMED AND THE TIP WAS LOCATED IN THE NASAL CAVITY. TUBE TIP WAS REMOVED WITHOUT INCIDENT. PT WAS ADMITTED IN 10/03 AND DISCHARGED IN 11/03. DURING THIS TIME, THE PT SPENT 48 HOURS IN ICU. PT RECOVERED COMPLETELY FROM UNDERLYING MEDICAL CONDITION AND WAS DISCHARGED. ONE PT INOVLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FLEXIFLO ENTERAL FEEDING TUBE 78 BSS TUBES, NASOGASTRIC BSS ROSS PRODUCTS DIVISION ABBOTT LABORATORIES 475 96-440-GZ

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Required Intervention