BEUDAMED
    FDA Adverse Event Injury Summary report: N

    12FR CORFLO ULTRA NASOGASTRIC TUBE

    MDR report key: 3926039 · Received July 1, 2014

    Report

    Report Number
    3009124963-2014-00021
    Event Type
    Injury
    Date Received
    July 1, 2014
    Date of Event
    May 20, 2014
    Report Date
    June 30, 2014
    Manufacturer
    CORPAK MEDSYSTEMS
    Product Code
    KNT
    PMA / PMN Number
    K821906
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    NO SAMPLE IS AVAILABLE FOR EVALUATION. PLACEMENT INTO THE LUNG IS A KNOWN RISK OF ANY FEEDING TUBE PLACEMENT PROCEDURE. FEEDING TUBE PLACEMENT IS DEPENDENT ON THE PATIENT AND CLINICIAN AND NOT THE TUBE ITSELF.

    Description of Event or Problem · 1

    AFTER SEVERAL ATTEMPTS OF A NASOGASTRIC TUBE PLACEMENT, THE TUBE WAS PLACED IN THE LEFT LUNG LEADING TO A PNEUMOTHORAX. THE PLACEMENT WAS REPORTED AS DIFFICULT DUE TO THE PATIENT BEING UNCOOPERATIVE AND COMBATIVE. AN X-RAY IMMEDIATELY AFTER INSERTION CONFIRMED LEFT LUNG PLACEMENT AND PNEUMOTHORAX. NO FEED WAS ADMINISTERED. A CHEST TUBE WAS PLACED AND REMOVED ON (B)(6) 2014 WITH THE PNEUMOTHORAX RESOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    381777 12FR CORFLO ULTRA NASOGASTRIC TUBE NASOGASTRIC FEEDING TUBE KNT CORPAK MEDSYSTEMS 20-7432 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 85 YR Other