BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTRODUCER KIT FOR GASTROSTOMY FEEDING TUBE, 24FR DILATOR

    MDR report key: 23211193 · Received October 3, 2025

    Report

    Report Number
    9611594-2025-00228
    Event Type
    Malfunction
    Date Received
    October 3, 2025
    Date of Event
    September 4, 2025
    Report Date
    October 24, 2025
    Manufacturer
    AVANOS MEDICAL INC.
    Product Code
    KGC
    UDI-DI
    00350770984346
    PMA / PMN Number
    K080253
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE HISTORY RECORD FOR THE REPORTED LOT NUMBER, 30355150, IN THIS COMPLAINT WAS REVIEWED AND THE MATERIAL WAS PRODUCED ACCORDING TO THE MANUFACTURING PROCEDURES AND MET THE QUALITY REQUIREMENTS. ROOT CAUSE COULD NOT BE DETERMINED. ALL INFORMATION REASONABLY KNOWN AS OF 24-OCT-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.

    Additional Manufacturer Narrative · 0

    THE DEVICE HISTORY RECORD FOR THE REPORTED LOT NUMBER, 30355150, IN THIS COMPLAINT WAS REVIEWED AND THE MATERIAL WAS PRODUCED ACCORDING TO THE MANUFACTURING PROCEDURES AND MET THE QUALITY REQUIREMENTS. THE ACTUAL COMPLAINT PRODUCT WAS NOT RETURNED FOR EVALUATION. ALL INFORMATION REASONABLY KNOWN AS OF (B)(6) 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 THAT THE SUTURES BROKE 48-HOURS AFTER INSERTION. "NO INCIDENTS DURING INSERTION, SIMPLE PROCEDURE. EXPERIENCED PROFESSIONAL, FAMILIAR EQUIPMENT. ON (B)(6) 2025 A 3-STAGE COMPUTED TOMOGRAPHY (CT) WITH INTRAVENOUS (IV) WAS PERFORMED AND IT NOTED: -AT THE ABDOMINOPELVIC LEVEL: GASTROSTOMY TUBE IN INTRAGASTRIC POSITION. -TUBES REMOVED WITH DISTAL METAL PART IN INTRAGASTRIC POSITION ON A DEPENDENT SLOPE. -NO ABSCESS OR BLEEDING LESION IDENTIFIED TODAY. -NO FOCAL PARIETAL THICKENING OF THE DIGESTIVE LOOPS WITHIN THE LIMITS OF THE EXAMINATION. -NON-SPECIFIC PNEUMOPERITONEUM FOLLOWING THE INSERTION OF A GASTROSTOMY TUBE. A SMALL AMOUNT. ACTIONS TAKEN IN THE HEALTHCARE FACILITY FOR THE PATIENT'S CARE INCLUDED "PATIENT MONITORING STRENGTHENED."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1842154 INTRODUCER KIT FOR GASTROSTOMY FEEDING TUBE, 24FR DILATOR DH EF PERC PLACEMENT PRODUCTS KGC AVANOS MEDICAL INC. 98434 30355150 00350770984346

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Male