BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MIC GJ FEED TUBE KIT-ENDOSCOPIC/RADIOLOGIC PLACEMENT-22 FR

    MDR report key: 25128350 · Received May 8, 2026

    Report

    Report Number
    9611594-2026-00289
    Event Type
    Malfunction
    Date Received
    May 8, 2026
    Report Date
    May 8, 2026
    Manufacturer
    AVANOS MEDICAL INC.
    Product Code
    KNT
    UDI-DI
    00350770954875
    PMA / PMN Number
    K921370
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ME, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THE ACTUAL SAMPLE FROM THE REPORTED EVENT WAS RETURNED FOR EVALUATION. A REVIEW OF THE DEVICE HISTORY RECORD FOR THE PROVIDED IS IN PROGRESS. ALL INFORMATION REASONABLY KNOWN AS OF 08-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 EVENT REPORTED BUT IS RELAYING THE INFORMATION THAT WAS PROVIDED BY THE USER FACILITY WHERE THE INCIDENT OCCURRED. THIS PRODUCT INCIDENT IS DOCUMENTED IN THE AVANOS MEDICAL, INC. 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

    AVANOS MEDICAL RECEIVED A SINGLE REPORT THAT REFERENCED TWO DIFFERENT INCIDENCES, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING TWO DIFFERENT EVENTS. THIS IS THE FIRST OF TWO REPORTS. REFER TO 9611594-2026-00295 FOR THE SECOND EVENT. IT WAS REPORTED THE FEEDING TUBE WAS BLOCKED AT THE CENTER OF THE ADAPTER, PREVENTING ADVANCEMENT OVER THE GUIDEWIRE DURING PLACEMENT. NO INJURY OR MEDICAL INTERVENTION WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    201026 MIC GJ FEED TUBE KIT-ENDOSCOPIC/RADIOLOGIC PLACEMENT-22 FR DH EF BALLOON TUBES PRODUCTS KNT AVANOS MEDICAL INC. 0250-22 30379336 00350770954875

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown