BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AVANOS

    MDR report key: 22827357 · Received August 18, 2025

    Report

    Report Number
    22827357
    Event Type
    Malfunction
    Date Received
    August 18, 2025
    Date of Event
    May 30, 2025
    Report Date
    August 6, 2025
    Manufacturer
    AVANOS MEDICAL, INC.
    Product Code
    KNT
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    6 FR. NGT [NASOGASTRIC TUBE] WAS PLACED IN A PATIENT AND BURST OPEN DURING MEDICATION ADMINISTRATION. UPON REMOVAL OF THE NGT, ONE CAN SEE THE SPLIT IN THE NGT TUBING. 6FR CORFLO NGT BURST WHILE INSIDE A PATIENT. RN WAS HAVING DIFFICULTY FLUSHING TUBING, APPLIED PRESSURE WITH WATER SYRINGE TO TROUBLESHOOT AND TUBING BURST. NGT WAS REMOVED AND TUBE WAS INTACT, NO FOREIGN OBJECTS REMAINED IN THE PATIENT. PART OF THE NGT BROKE OPEN WHILE THE RN WAS TROUBLESHOOTING THE CLOGGED TUBE. THIS IS THE FIRST OF 3 TUBES WHICH HAVE BURST WHILE BEING INSIDE THIS PATIENT. RNS ARE PROPERLY FLUSHING TUBE BETWEEN MEDS AND PRIOR TO/AFTER MEDICATION ADMINISTRATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1589848 AVANOS TUBES, GASTROINTESTINAL (AND ACCESSORIES) KNT AVANOS MEDICAL, INC. 40-9366 30364855

    Patients

    Seq Age Sex Outcome Treatment
    1 1 MO Male