BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTRODUCER KIT FOR GASTROSTOMY FEEDING TUBE, 24FR DILATOR

    MDR report key: 22815110 · Received August 15, 2025

    Report

    Report Number
    9611594-2025-00181
    Event Type
    Malfunction
    Date Received
    August 15, 2025
    Date of Event
    July 10, 2025
    Report Date
    November 13, 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

    CORRECTION D9: DATE. THE DEVICE HISTORY RECORD FOR THE REPORTED LOT NUMBER, 30335217, IN THIS COMPLAINT WAS REVIEWED AND THE MATERIAL WAS PRODUCED ACCORDING TO THE MANUFACTURING PROCEDURES AND MET THE QUALITY REQUIREMENTS. THE SAMPLE PROVIDED WAS EVALUATED CONFIRMING TWO OF THE FOUR SUTURES ONLY SUTURE AND SOFTSHELL WAS RECEIVED FOR THIS SAMPLE. THE APPROXIMATE MEASUREMENT OF SUTURE BIOSYN ON THE BASE SIDE OF SOFTSHELL WAS APPROXIMATELY ONE-HALF INCH WHILE ON THE LOCKING CLIP SIDE WAS APPROXIMATELY ONE INCH. CLEARLY, THERE WAS SUTURE DAMAGE OBSERVED, THE OTHER TWO SUTURES WERE REVIEWED, NO OBVIOUS DAMAGES OR BREAKING OBSERVED FOR THE TWO SUTURE ASSEMBLIES. ROOT CAUSE COULD NOT BE DETERMINED. ALL INFORMATION REASONABLY KNOWN AS OF 13-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.

    Additional Manufacturer Narrative · 0

    THE DEVICE HISTORY RECORD FOR THE REPORTED LOT NUMBER, 30335217, IN THIS COMPLAINT WAS REVIEWED AND THE MATERIAL WAS PRODUCED ACCORDING TO THE MANUFACTURING PROCEDURES AND MET THE QUALITY REQUIREMENTS. THE ACTUAL SAMPLE FROM THE REPORTED EVENT WAS RETURNED FOR EVALUATION. ALL INFORMATION REASONABLY KNOWN AS OF 14-AUG-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 21 CFR 803, 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 THE "STERILE INFLATION OF THE STOMACH AND ANCHORING OF THE ANTERIOR WALL OF THE STOMACH TO THE ANTERIOR WALL OF THE ABDOMEN UNDER FLUOROSCOPIC CONTROL" WAS PERFORMED. THERE WAS A "GASTRIC PUNCTURE AND DILATATION OF THE PUNCTURE TRACT ON A METAL GUIDE WIRE. THE ANCHORS FELL OUT WHEN THE PRELIMINARY INTRODUCER WAS INSERTED." THIS WAS "PLACEMENT OF A 20F GASTROSTOMY TUBE. THE BALLOON [WAS] INFLATED WITH 10 CC OF SALINE." WALL THICKNESS WAS 3 CM." THIS WAS NOTED TO BE A SIMPLE PROCEDURE." THE PATIENT IS REPORTED TO BE STABLE. THERE WAS NO REPORTED INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2726826 INTRODUCER KIT FOR GASTROSTOMY FEEDING TUBE, 24FR DILATOR DH EF PERC PLACEMENT PRODUCTS KGC AVANOS MEDICAL INC. 98434 30335217 00350770984346

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Female