BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENTRFLX 12FR;43IN W/STYL YPOR

    MDR report key: 8687528 · Received June 11, 2019

    Report

    Report Number
    9612030-2019-02197
    Event Type
    Malfunction
    Date Received
    June 11, 2019
    Date of Event
    January 31, 2019
    Report Date
    June 11, 2019
    Manufacturer
    COVIDIEN
    Product Code
    KNT
    UDI-DI
    10884521583030
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINANT INDICATED THAT THE DEVICE WILL NOT BE RETURNED FOR EVALUATION; THEREFORE, A FAILURE ANALYSIS IS NOT AVAILABLE, AND WE ARE NOT ABLE TO DETERMINE THE RELATIONSHIP BETWEEN THIS DEVICE AND THE CAUSE FOR THIS EVENT. IF ADDITIONAL INFORMATION OR THE SAMPLE IS RECEIVED, THE INVESTIGATION WILL BE REOPENED AND RESPONDED TO ACCORDINGLY.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT ON (B)(6) 2019 A NJT WAS PLACED DURING ENDOSCOPY WITH ORDERS TO COMMENCE ENTERAL FEEDS 4/24 FLUSHES. THE NEXT DAY THE FEEDING TUBE WAS UNABLE TO BE FLUSHED DUE TO RESISTANCE FELT. AN ABDOMINAL X-RAY WAS DONE. THE PHYSICIAN ASKED FOR THE TUBE TO BE PULLED OUT 10CM. THE FEEDING TUBE WAS STILL UNABLE TO BE FLUSHED. THE FEEDING TUBE WAS REMOVED AND A KINK WAS NOTED AT APPROXIMATELY THE 20CM MARK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    479464 ENTRFLX 12FR;43IN W/STYL YPOR TUBES, GASTROINTESTINAL (AND ACCESSORIES) KNT COVIDIEN 8884721252E UNKNOWN 10884521583030

    Patients

    Seq Age Sex Outcome Treatment
    1