BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CORLITE ENTERAL FEEDING TUBE WITH ENFIT CONNECTOR

    MDR report key: 8784950 · Received July 11, 2019

    Report

    Report Number
    MW5088032
    Event Type
    Injury
    Date Received
    July 11, 2019
    Date of Event
    June 12, 2019
    Report Date
    July 9, 2019
    Manufacturer
    CORPAK MEDSYSTEMS, INC. / MEDICAL INDUSTRIES, INC.
    Product Code
    KNT
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    OH, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    THE HOSP RECENTLY CONVERTED TO NEW ENFIT TIP NG TUBES. EVENTS SUCH AS THE ONE ABOUT TO BE DESCRIBED OCCURRED WITH OTHER PTS IN A SIMILAR WAY DURING A SIMILAR TIMEFRAME. THIS PARTICULAR PT WAS IN THE NICU WITH A FEEDBAG IN PLACE. NURSING ATTEMPTED TO REMOVE THE FEEDBAG TO ADMINISTER MEDICATION. THE TUBING OF THE FEEDBAG WAS STUCK IN THE ENFIT TIP OF TUBE. NURSING ATTEMPTED TO REMOVE VIA GLOVED HANDS THEN WITH HEMOSTAT TO NO AVAIL. THE NG TUBE HAD TO THEN BE REPLACED WITH A WHOLE NEW SET TO ADMINISTER MEDICATION. OTHER SIMILAR EVENTS OCCURRED WITH OTHER PTS WHICH ALSO INVOLVED BREAKAGE OF THESE NEW ENTERAL TUBES. FDA SAFETY REPORT ID# (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    577207 CORLITE ENTERAL FEEDING TUBE WITH ENFIT CONNECTOR ENTERAL SINGLE PORT TUBES, GASTROINTESTINAL (AND ACCESSORIES) KNT CORPAK MEDSYSTEMS, INC. / MEDICAL INDUSTRIES, INC. 41-1225 77853

    Patients

    Seq Age Sex Outcome Treatment
    1 2 MO Required Intervention