BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GABRIEL FEEDING TUBE

    MDR report key: 790340 · Received November 30, 2006

    Report

    Report Number
    1066607-2006-00002
    Event Type
    Injury
    Date Received
    November 30, 2006
    Date of Event
    November 3, 2006
    Report Date
    November 30, 2006
    Manufacturer
    SYNCRO MEDICAL INNOVATIONS, INC.
    Product Code
    KNT
    PMA / PMN Number
    K021991
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    A MAGNETICALLY GUIDED FEEDING TUBE WAS MISPLACED INTO THE LUNG OF A PT WITH STAGE 4 METASTATIC LUNG CANCER RESULTING IN A TEMPORARY PNEUMOTHORAX. THE TUBE WAS INSERTED 6 INCHES BEFORE THE FIRST MARK. THE PROXIMAL END OF THE TUBE WAS PLACED UNDER WATER. NO RHYTHMIC BUBBLES WERE OBSERVED. THIS IS SUGGESTIVE OF CORRECT ESOPHAGEAL PLACEMENT AND THE PROCEDURE CONTINUED. THE TUBE WAS FURTHER ADVANCED, AND THOUGHT TO BE IN THE PROPER POSITION. 5 CC'S WATER AND 5 CC'S OF AIR WERE INFUSED AND AN ASPIRATE WAS OBTAINED SHOWING A PH OF 8. THE PT NEVER COUGHED WHEN THE WATER AND AIR WERE INFUSED. THE ABSENCE OF COUGHING AFTER THE ADMINSTRATION OF WATER AND AIR IS SUGGESTIVE OF CORRECT TUBE PLACEMENT. FINAL PLACEMENT CONFIRMATION BY RADIOGRAPHY AS RECOMMENDED BY THE DEVICE INSTRUCTION FOR USE REVEALED THE MISPLACED FEEDING TUBE. A CT WAS PERFORMED TO CONFIRM TUBE PLACEMENT. FINAL PLACEMENT CONFIRMATION BY RADIOGRAPH AS RECOMMENDED BY THE DEVICE INSTRUCTION FOR USE REVEALED THE MISPLACED FEEDING TUBE. A CT WAS PERFORMED TO CONFIRM TUBE PLACEMENT. THE TUBE WAS REMOVED AND THE DEVELOPED PNEUMOTHORAX WAS CORRECTED BY THE TREATING PHYSICIAN USING A CHEST TUBE. NO FURTHER OCMPLICATIONS RELATED TO THE FEEDING TUBE WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GABRIEL FEEDING TUBE FEEDING TUBE KNT SYNCRO MEDICAL INNOVATIONS, INC. GFT 112 C1-00214

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Required Intervention