BEUDAMED
    FDA Adverse Event Other Summary report: N

    COMPAT NASOGASTRIC TUBE 10 FR

    MDR report key: 1810615 · Received August 5, 2010

    Report

    Report Number
    2110851-2010-00005
    Event Type
    Other
    Date Received
    August 5, 2010
    Date of Event
    June 16, 2010
    Report Date
    July 30, 2010
    Manufacturer
    NESTLE HEALTHCARE NUTRITION, INC.
    Product Code
    FPD
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    SUSPECT DEVICE WAS NOT RETURNED TO MANUFACTURER. PRODUCT SAMPLES FROM SAME LOT WERE TESTED AND ALL DEVICES MET SPECIFICATION. TEST REPORT IS ATTACHED.

    Description of Event or Problem · 1

    AS REPORTED BY HEALTHCARE FACILITY: THE RN WAS UNABLE TO ADVANCE THE DOBHOFF TUBE. THE DEVICE MALFUNCTIONED. THE PATIENT WAS COUGHING SO THE TUBE WAS REMOVED. WHEN THE TUBE WAS REMOVED A SLIGHT RESISTANCE WAS FELT. THE DOBHOFF CAME OUT WITHOUT THE WEIGHTED END (TIP). THE PULMONARY MD WAS CONSULTED. A CXR AND KIDNEY, URETER AND BLADDER (KUB) X-RAY WERE DONE. A CT SCAN OF THE CHEST WAS DONE. THE CT SCAN REVEALED A LINEAR FOREIGN BODY IN THE LEFT LOWER LOBE ATELECTASIS. THE TIP WAS REMOVED BY BRONCHOSCOPY AND A CXR WAS TAKEN. THE PHYSICIAN ATTEMPTED TO PULL THE TIP OFF OF A NEW DOBHOFF AND EVEN WITH EXTREME PRESSURE WAS UNABLE TO PULL OFF OR SEPARATE THE TIP FROM THE REST OF THE TUBING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COMPAT NASOGASTRIC TUBE 10 FR TUBES, GASTROINTESTINAL AND ACCESSORIES FPD NESTLE HEALTHCARE NUTRITION, INC. 083106 1529FX

    Patients

    Seq Age Sex Outcome Treatment
    1 Other