BEUDAMED
    FDA Adverse Event Other Summary report: N

    *

    MDR report key: 826349 · Received September 20, 2005

    Report

    Report Number
    1018233-2005-00068
    Event Type
    Other
    Date Received
    September 20, 2005
    Product Code
    FEG
    Report Source
    Manufacturer report

    Narratives

    Additional Manufacturer Narrative · 1

    THERE WAS NO ALLEGED FAILURE OF THE DEVICE TO PERFORM ITS INTENDED PURPOSE AND THERE WAS NO INJURY TO THE PT. THE ACCOUNT ACKNOWLEDGED THAT ASCULTATION IS AN ACCEPTED METHOD OF CHECKING PLACEMENT WHILE CONFIRMATION BY RADIATION IS GOLD STANDARD, BUT NOT PRACTICAL OR COST EFFECTIVE. A REVIEW OF THE PRODUCT LABELING SHOWED IN THE NOTE SECTION: "TO CONFIRM PROPER PLACEMENTOF NASOGASTRIC SUMP TUBE, PERFORM THE FOLLOWING: RAPIDLY INJECT 10-20CC OF AIR THROUGH THE BLUE AIR VENT LUMEN WHILE AUSCULATING THE ABDOMEN. THE RUSH OF AIR AS IT ENTERS THE STOMACH WILL BE HEARD IF THE TUBE IS CORRECTLY PLACED. ASPIRATE GENTLY TO OBTAIN STOMACH CONTENTS. X-RAYS MAY BE DONE TO CONFIRM TUBE PLACEMENT".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 * FEG

    Patients

    Seq Age Sex Outcome Treatment
    1 Other