BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTRODUCER KIT FOR GASTROSTOMY FEED TUBE, 18FR DILATOR

    MDR report key: 24392211 · Received February 19, 2026

    Report

    Report Number
    9611594-2026-00076
    Event Type
    Malfunction
    Date Received
    February 19, 2026
    Date of Event
    January 23, 2026
    Report Date
    May 6, 2026
    Manufacturer
    AVANOS MEDICAL INC.
    Product Code
    KGC
    UDI-DI
    00350770984315
    PMA / PMN Number
    K080253
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    HEALTH EFFECT: CLINICAL CODE/NO CODE: SKIN CUT. THE ACTUAL COMPLAINT PRODUCT WAS NOT RETURNED FOR EVALUATION. A REVIEW OF THE DEVICE HISTORY RECORD AND UDI NUMBER ARE IN-PROGRESS. ALL INFORMATION REASONABLY KNOWN AS OF 19-FEB-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

    IT WAS REPORTED THAT A NURSE CUT THE TIP OF HIS FINGER WITH THE #11 SCALPEL INCLUDED IN THE KIT AND REQUIRED STITCHES. THE CUT WAS MINOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    311470 INTRODUCER KIT FOR GASTROSTOMY FEED TUBE, 18FR DILATOR DH EF PERC PLACEMENT PRODUCTS KGC AVANOS MEDICAL INC. 98431 30356611 00350770984315

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other