BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTRODUCER KIT FOR GASTROSTOMY FEEDING TUBE, 20FR DILATOR

    MDR report key: 23503627 · Received November 7, 2025

    Report

    Report Number
    9611594-2025-00270
    Event Type
    Malfunction
    Date Received
    November 7, 2025
    Date of Event
    October 2, 2025
    Report Date
    March 25, 2026
    Manufacturer
    AVANOS MEDICAL INC.
    Product Code
    KGC
    UDI-DI
    00350770984322
    PMA / PMN Number
    K080253
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE HISTORY RECORD FOR THE REPORTED LOT NUMBER, 30371254, IN THIS COMPLAINT WAS REVIEWED AND THE MATERIAL WAS PRODUCED ACCORDING TO THE MANUFACTURING PROCEDURES AND MET THE QUALITY REQUIREMENTS. THE SAMPLE WAS EVALUATED. NO ORIGINAL PACKAGING RECEIVED, THE REST OF THE DILATOR COMPONENTS WERE RETURNED AND THEY ARE AS FOLLOWS: THE ENTIRETY OF THE DEVICE WAS OBSERVED. IT APPEARED THAT THE PEEL AWAY SHEATH WAS NOT COMPLETELY SEPARATED INTO TWO ON ITS PERFORATED LINES. THE PEEL AWAY SHEATH WAS INSPECTED UNDER MAGNIFICATION, AND IT APPEARED TO HAVE KINKS BELOW THE YELLOW WINGS. ALSO OBSERVED WAS THAT THE 12FR TUBE SIZE AND CENTRAL CANNULA WAS SEPARATED FROM THE OTHER TUBES. THE CENTRAL CANNULA WHEN ASSEMBLED (NOT DAMAGED), THE COMPLETED DEVICE HAD A WHITE TIP ON THE DISTAL END DESIGNED TO BE A MECHANICAL STOP FOR THE OTHER TUBES. SINCE THE REST OF THE TUBE SIZES WERE RETURNED SEPARATED FROM THE CANNULA, THE CENTRAL CANNULA TIP WAS INSPECTED UNDER MAGNIFICATION (10X). THE (12FR) TUBE ALSO EXHIBITED WHEN INSPECTED UNDER MAGNIFICATION IS DESIGNED TO ADVANCE UNTIL THE DISTAL TIP MECHANICALLY STOPS THE TUBE FROM ADVANCING. THE RETURNED 12FR TUBE SAMPLE HAD DAMAGE ON THE TIP OF THE TUBE WHICH WOULD BYPASS THE MECHANICAL STOP TEN TIMES. ROOT CAUSE COULD NOT BE DETERMINED. ALL INFORMATION REASONABLY KNOWN AS OF 25-MAR-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.

    Additional Manufacturer Narrative · 0

    THE ACTUAL COMPLAINT PRODUCT WAS RETURNED FOR EVALUATION. A REVIEW OF THE DEVICE HISTORY RECORD IS NOT POSSIBLE AS NO LOT NUMBER WAS PROVIDED; THEREFORE, THE UDI-PI IS UNAVAILABLE. THE LOT NUMBER WAS NOT PROVIDED BY THE CUSTOMER. ALL INFORMATION REASONABLY KNOWN AS OF 07-NOV-2025 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

    IT WAS REPORTED THERE WAS AN ISSUE WITH "20FR SERIAL DILATOR WITH A PEEL-AWAY SHEATH. THE DILATORS WOULD NOT DEPLOY. IT ENDED UP BENDING AND GETTING STUCK IN THE PATIENT." THERE WAS NO REPORTED INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1925175 INTRODUCER KIT FOR GASTROSTOMY FEEDING TUBE, 20FR DILATOR DH EF PERC PLACEMENT PRODUCTS KGC AVANOS MEDICAL INC. 98432 30371254 00350770984322

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown