BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNKNOWN NASOGASTRIC TUBES

    MDR report key: 25093454 · Received May 6, 2026

    Report

    Report Number
    9611594-2026-00279
    Event Type
    Malfunction
    Date Received
    May 6, 2026
    Date of Event
    March 5, 2025
    Report Date
    May 6, 2026
    Manufacturer
    AVANOS MEDICAL INC.
    Product Code
    KNT
    PMA / PMN Number
    UNKNOWN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS EVENT WAS INITIALLY DEEMED NOT REPORTABLE BASED ON OUR REPORTING STRATEGY ACTIVE AT THE TIME OF THE ALERT DATE; HOWEVER, FOLLOWING A RECENT RETROSPECTIVE REVIEW OF COMPLAINTS THIS EVENT WAS MADE REPORTABLE OUT OF AN ABUNDANCE OF CAUTION. A REVIEW OF THE DEVICE HISTORY RECORD IS NOT POSSIBLE AS NO LOT NUMBER WAS PROVIDED; THEREFORE, THE UDI-PI IS UNAVAILABLE. THE ACTUAL COMPLAINT PRODUCT WAS RETURNED FOR EVALUATION. JAGGED TEARS WERE OBSERVED IN THE TUBING, NEAR THE CONNECTOR. THE TEARS ARE ON VARYING SIDES OF THE TUBING. THEY EXTEND FROM JUST BELOW THE BASE OF THE ENFIT CONNECTOR TO APPROXIMATELY 3CM DOWN THE TUBING. THE TUBE WAS CUT LATERALLY, BELOW THE BASE OF THE CONNECTOR. THEN, ON AN OPPOSITE WALL FROM THE TEARS, THE TUBING WAS CUT AXIALLY, IN ORDER TO VIEW THE INNER WALL. THE INNER WALL OF THE TUBING EXHIBITS SIMILAR TEARING AND SURFACE ABRASIONS. A ROOT CAUSE HAS NOT BEEN ESTABLISHED. ALL INFORMATION REASONABLY KNOWN AS OF 06 MAY 2026 HAS BEEN INCLUDED IN THIS HEALTH AUTHORITY REPORT. SHOULD ADDITIONAL INFORMATION BE OBTAINED, A FOLLOW-UP HEALTH AUTHORITY REPORT WILL BE PROVIDED. THE INFORMATION PROVIDED BY AVANOS MEDICAL INC. REPRESENTS ALL OF THE KNOWN INFORMATION AT THIS TIME. DESPITE GOOD FAITH EFFORTS TO OBTAIN ADDITIONAL INFORMATION, THE COMPLAINANT/REPORTER WAS UNABLE OR UNWILLING TO PROVIDE ANY FURTHER PATIENT, PRODUCT, OR PROCEDURAL DETAILS TO AVANOS MEDICAL INC. AVANOS MEDICAL INC. HAS NO INDEPENDENT KNOWLEDGE OF THE REPORTED EVENT BUT IS RELAYING THE INFORMATION PROVIDED BY THE USER FACILITY WHERE THE INCIDENT OCCURRED. THIS PRODUCT INCIDENT IS DOCUMENTED IN THE AVANOS MEDICAL COMPLAINT DATABASE AND IDENTIFIED AS COMPLAINT (B)(4). THIS INFORMATION IS SUBMITTED PURSUANT TO 21CFR803, IN COMPLIANCE WITH THE MEDICAL DEVICE REPORTING REQUIREMENT AND SHOULD NOT BE CONSIDERED TO BE AN ADMISSION THAT AN AVANOS MEDICAL INC. PRODUCT IS DEFECTIVE OR CAUSED SERIOUS INJURY.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A NASOJEJUNAL FEEDING TUBE INSERTED INTO THE PATIENT. ONCE IN POSITION, THE TUBE WAS USED AND FOUND TO BE LEAKING NEAR THE HUB.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    526256 UNKNOWN NASOGASTRIC TUBES DH CPK NG TUBES KNT AVANOS MEDICAL INC. UNKNOWN UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female