BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CORTRAK EAS SYSTEM

    MDR report key: 3021504 · Received March 11, 2013

    Report

    Report Number
    3009124963-2013-00008
    Event Type
    Injury
    Date Received
    March 11, 2013
    Date of Event
    January 16, 2013
    Report Date
    March 8, 2013
    Manufacturer
    CORPAK MEDSYSTEMS
    Product Code
    KNT
    PMA / PMN Number
    K821906
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE FEEDING TUBE WAS NOT RETURNED FOR EVALUATION. THE CORTRAK SYSTEM USED FOR THE INITIAL PLACEMENT OF THE FEEDING TUBE (SERIAL #(B)(4)) WAS EVALUATED AND FOUND TO MEET SPECIFICATIONS AND BE FULLY FUNCTIONAL. IN ADDITION THE TRACING FROM THE INITIAL PLACEMENT WAS REVIEWED AND IS REPRESENTATIVE OF A GI PLACEMENT. INITIAL PLACEMENT WAS ALSO CONFIRMED VIA X-RAY. THE TUBE WAS FOUND COILED 11 DAYS AFTER INITIAL PLACEMENT. IT IS UNCLEAR HOW THE NASOGASTRIC TUBE BECAME COILED IN THE PATIENT'S THROAT. THERE ARE SEVERAL FACTORS WHICH COULD CAUSE THE TUBE TO BE DISPLACED INCLUDING PULLING BY THE PATIENT, MOVEMENT DURING ANOTHER MEDICAL PROCEDURE, VOMITING, COUGHING ETC. IT IS NOT POSSIBLE, DUE TO PERISTALSIS, FOR A FEEDING TUBE TO MIGRATE UPWARD OUT OF THE STOMACH.

    Description of Event or Problem · 1

    EVENT DESCRIPTION: A CORTRAK NASOGASTRIC TUBE WAS INSERTED WITHOUT INCIDENT ON (B)(6) 2013. ON (B)(6) 2013 THE TUBE WAS DISCOVERED COILED IN THE BACK OF THE THROAT CAUSING "SEVERE RESPIRATORY DISTRESS, TRANSFER BACK TO ICU AND SUBSEQUENT RE-INTUBATION." PHYSICIAN AND PRIMARY RN CONCERNED ABOUT THE POSSIBILITY OF THIS NON-WEIGHTED FEEDING TUBE HAVING HAD MIGRATED ON ITS OWN BACK INTO THE STOMACH FROM THE SMALL INTESTINE AND THEN UP ESOPHAGUS INTO THE THROAT. PRIMARY RN NOTED SOME COUGHING PRIOR TO THE EVENT HOWEVER NO VOMITING OR RETCHING WAS REPORTED. DOCUMENTATION IN PATIENT'S CHART INDICATES PATIENT VERY DEPRESSED ON (B)(6) 2013; THEREFORE PATIENT INTERFERENCE CANNOT BE RULED OUT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    102456 CORTRAK EAS SYSTEM FEEDING TUBE KNT CORPAK MEDSYSTEMS 20-9431TRAK2 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other