BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENTRFLX 10FR;43IN W/STY YPORT

    MDR report key: 10384521 · Received August 10, 2020

    Report

    Report Number
    9612030-2020-02556
    Event Type
    Malfunction
    Date Received
    August 10, 2020
    Date of Event
    May 14, 2020
    Report Date
    August 10, 2020
    Manufacturer
    COVIDIEN
    Product Code
    KNT
    UDI-DI
    10884521582996
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    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 REPORTED THAT THE GUIDEWIRE WOULD NOT COME OFF OF THE NASOGASTRIC TUBE AFTER INSERTION OF THE TUBE. IT COULD NOT BE REMOVED. THE PATIENT EXPERIENCED DISCOMFORT. A NEW NASOGASTRIC TUBE MUST BE INSERTED WHEN THE REMOVAL OF THE GUIDE WIRE IS IMPOSSIBLE. BEFORE INSERTING THE NASOGASTRIC TUBE, THE GUIDEWIRE MUST BE PULLED 10 TO 15 CMS IN ORDER TO BE ABLE TO THEN REMOVE IT AFTER THE NASOGASTRIC TUBE HAS BEEN INSERTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    848841 ENTRFLX 10FR;43IN W/STY YPORT TUBES, GASTROINTESTINAL (AND ACCESSORIES) KNT COVIDIEN 8884721088E 1733188164 10884521582996

    Patients

    Seq Age Sex Outcome Treatment
    1