BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CORFLO NG TUBE

    MDR report key: 1871292 · Received October 13, 2010

    Report

    Report Number
    1419949-2010-00012
    Event Type
    Injury
    Date Received
    October 13, 2010
    Date of Event
    September 19, 2010
    Report Date
    October 8, 2010
    Manufacturer
    CORPAK MEDSYSTEMS
    Product Code
    KNT
    PMA / PMN Number
    K821906
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    FEEDING TUBE PLACEMENT IS DEPENDENT ON THE USER NOT THE FEEDING TUBE. NEITHER THE FEEDING TUBE OR THE CORTRAK WERE RETURNED TO CORPAK FOR EVAL. HOWEVER, THE ELECTRONIC PLACEMENT FILE, FROM THE CORTRAK, WAS FORWARDED FOR OUR REVIEW. THE PLACEMENT WAS REVIEWED AND SHOWED THE FEEDING TUBE IN THE LEFT LUNG.

    Description of Event or Problem · 1

    THE CORTRAK WAS USED TO PLACE A NG TUBE ON (B)(6) 2010, EVENING. PT WAS FED FOR 4 HOURS AT 30ML/HR THEN FOR 3 HOURS AT 60ML/HR-TOTAL 7 HOURS OF CONTINUOUS FEED (TOTAL OF 300ML). AFTER FEEDING THE PT HAD AN X-RAY WHICH CONFIRMED TUBE WAS IN BRONCHUS NOT THE STOMACH. THE PT WAS ON ASSISTED VENTILATION, NOW ON 40% OXYGEN AND CONTINUED ANTIBIOTICS AND HAS NOW IMPROVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CORFLO NG TUBE NG TUBE KNT CORPAK MEDSYSTEMS NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other