BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENTRFLX 12FR;43IN W/STYL YPOR

    MDR report key: 8624424 · Received May 20, 2019

    Report

    Report Number
    9612030-2019-02181
    Event Type
    Malfunction
    Date Received
    May 20, 2019
    Date of Event
    March 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 · 0

    SECTION B5 WAS UPDATED FROM "THE CUSTOMER REPORTS THAT THERE WAS DIFFICULTY FLUSHING THE DEVICE. UPON REMOVAL OF THE TUBE A KINK WAS NOTICED AT APPROXIMATELY 10CM. THE NJT WAS REPLACED. THE PATIENT WAS EDUCATED REGARDING HOME FEEDS AND FLUSHING. THE NJT BLOCKED AT HOME AND WHEN THE PATIENT CHANGED THE NASO FIX DRESSING SHE NOTED THAT THERE WAS A HOLE IN THE TUBE JUST NEAR INSERTION." TO "THE CUSTOMER REPORTS THAT THE PATIENT WAS ADMITTED ON (B)(6) 2019 FOR INSERTION OF A NJT DURING X-RAY FOR ENTERAL FEEDING. THEY EXPERIENCED DIFFICULTY FLUSHING THE NJT ONCE THE PATIENT RETURNED TO THE WARD. THE NEXT MORNING THE CONSULTANT REVIEWED THE X-RAY AND ASKED FOR THE TUBE TO BE REMOVED 10CM, SAME ISSUE OCCURRED, THEY WERE UNABLE TO FLUSH. THE NJT WAS REMOVED AND A KINK WAS NOTED AT APPROXIMATELY 10CM." THE ISSUE RELATED TO THE NJT THAT WAS BLOCKED AND HAD A HOLE IS REFLECTED ON THE INITIAL REPORT NUMBER.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTS THAT THE PATIENT WAS ADMITTED ON (B)(6) 2019 FOR INSERTION OF A NJT DURING X-RAY FOR ENTERAL FEEDING. THEY EXPERIENCED DIFFICULTY FLUSHING THE NJT ONCE THE PATIENT RETURNED TO THE WARD. THE NEXT MORNING THE CONSULTANT REVIEWED THE X-RAY AND ASKED FOR THE TUBE TO BE REMOVED 10CM, SAME ISSUE OCCURRED, THEY WERE UNABLE TO FLUSH. THE NJT WAS REMOVED AND A KINK WAS NOTED AT APPROXIMATELY 10CM.

    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 REPORTS THAT THERE WAS DIFFICULTY FLUSHING THE DEVICE. UPON REMOVAL OF THE TUBE A KINK WAS NOTICED AT APPROXIMATELY 10CM. THE NJT WAS REPLACED. THE PATIENT WAS EDUCATED REGARDING HOME FEEDS AND FLUSHING. THE NJT BLOCKED AT HOME AND WHEN THE PATIENT CHANGED THE NASO FIX DRESSING SHE NOTED THAT THERE WAS A HOLE IN THE TUBE JUST NEAR INSERTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    418762 ENTRFLX 12FR;43IN W/STYL YPOR TUBES, GASTROINTESTINAL (AND ACCESSORIES) KNT COVIDIEN 8884721252E UNKNOWN 10884521583030

    Patients

    Seq Age Sex Outcome Treatment
    1