BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CORPAK

    MDR report key: 1811986 · Received August 17, 2010

    Report

    Report Number
    1419949-2010-00009
    Event Type
    Injury
    Date Received
    August 17, 2010
    Date of Event
    July 11, 2010
    Report Date
    July 28, 2010
    Manufacturer
    CORPAK MEDSYSTEMS
    Product Code
    KNT
    PMA / PMN Number
    K821906
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    FEEDING TUBE PLACEMENT IS DEPENDENT ON THE CLINICIAN AND PATIENT. THE ACTUAL TUBE DOES NOT INFLUENCE WHERE IT IS PLACED.

    Description of Event or Problem · 1

    THE PATIENT WAS ADMITTED FOR PERITONITIS AND DEHYDRATION. THE PATIENT WAS STARTED ON NASOGASTRIC FEEDING (NG). THE NG TUBE BECAME PARTIALLY DISLODGED AND WAS REINSERTED BY THE PATIENT'S MOTHER. THE NG PLACEMENT WAS CONFIRMED PER ASCULTATION BY TWO RN'S ON DAY SHIFT AND ONE ON NIGHT SHIFT. THE NEXT DAY THE PATIENT BECAME FEBRILE. AN X-RAY WAS DONE WHICH CONFIRMED PLACEMENT INTO THE RIGHT BRONCHUS. THE FEEDING WAS STOPPED, THE RAPID RESPONSE TEAM CALLED AND THE PATIENT WAS TRANSFERRED TO THE INTENSIVE CARE UNIT. THE PATIENT HAS SINCE RECOVERED FROM THE INCIDENT AND IS OUT OF THE INTENSIVE CARE UNIT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CORPAK CORFLO ULTRA PEDI NG WT W/STYLET KNT CORPAK MEDSYSTEMS NA UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 19 YR Other