BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENTRFLX 12FR;43IN W/STYL YPOR

    MDR report key: 8623955 · Received May 20, 2019

    Report

    Report Number
    9612030-2019-02180
    Event Type
    Malfunction
    Date Received
    May 20, 2019
    Date of Event
    December 12, 2018
    Report Date
    May 20, 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 INCIDENT SAMPLE HAS BEEN REQUESTED BUT TO DATE HAS NOT BEEN RECEIVED FOR EVALUATION. IF THE SAMPLE IS RECEIVED, OR IF ADDITIONAL INFORMATION PERTINENT TO THE INCIDENT IS OBTAINED A FOLLOW-UP REPORT WILL BE SUBMITTED. AS PART OF OUR MANUFACTURING PROCESS, ALL DEVICE HISTORY RECORDS ARE REVIEWED AND APPROVED BY QUALITY, PRIOR TO RELEASE OF PRODUCT.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTS THAT THE PATIENT HAD A NJT INSERTED VIA ENDOSCOPY FOR FEEDING AT HOME. THE NJT WAS ABLE TO BE FLUSHED BEFORE DISCHARGE. ON (B)(6) 2019 THE TUBE WAS BLOCKED AND WAS TAKEN OUT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    417330 ENTRFLX 12FR;43IN W/STYL YPOR TUBES, GASTROINTESTINAL (AND ACCESSORIES) KNT COVIDIEN 8884721252E UNKNOWN 10884521583030

    Patients

    Seq Age Sex Outcome Treatment
    1