BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MIC-KEY LOW-PROFILE GASTROSTOMY FEEDING TUBE

    MDR report key: 22396853 · Received July 3, 2025

    Report

    Report Number
    9611594-2025-00143
    Event Type
    Injury
    Date Received
    July 3, 2025
    Report Date
    July 23, 2025
    Manufacturer
    AVANOS MEDICAL INC.
    Product Code
    KNT
    UDI-DI
    00350770948478
    PMA / PMN Number
    K043114
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE PRODUCT INVOLVED IN THE REPORT HAS BEEN RETURNED AND THE INVESTIGATION REMAINS IN PROGRESS AT THIS TIME. A REVIEW OF THE DEVICE HISTORY RECORD AND UDI ARE IN-PROGRESS. ALL INFORMATION REASONABLY KNOWN AS OF 03 JUL 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 REPORTED EVENT BUT IS RELAYING THE INFORMATION PROVIDED BY THE USER FACILITY WHERE THE INCIDENT OCCURRED. THIS PRODUCT INCIDENT IS DOCUMENTED IN THE AVANOS MEDICAL 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 LOT 30334056 WAS REVIEWED AND THE PRODUCT WAS PRODUCED ACCORDING TO PRODUCT SPECIFICATIONS. THE ACTUAL COMPLAINT PRODUCT WAS RETURNED FOR EVALUATION. THE SAMPLE PROVIDED CONFIRMS THE LEAK THROUGH THE DUCKBILL VALVE DUE TO THE SLIT OF THE VALVE WAS IN AN OPEN POSITION. A POTENTIAL ROOT CAUSE HAS BEEN IDENTIFIED AS - EQUIPMENT : INCORRECT PREVENTIVE MAINTENANCE SCHEDULE. THE FREQUENCY FOR REPLACEMENT OF BLADES IN CUTTING MACHINE WILL BE DEFINED IN PREVENTIVE MAINTENANCE PROGRAM AND INSTRUCTIONS DOCUMENTED IN LOCAL MAINTENANCE WORK INSTRUCTIONS. ALL INFORMATION REASONABLY KNOWN AS OF 23 JUL 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 REPORTED EVENT BUT IS RELAYING THE INFORMATION PROVIDED BY THE USER FACILITY WHERE THE INCIDENT OCCURRED. THIS PRODUCT INCIDENT IS DOCUMENTED IN THE AVANOS MEDICAL 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, GASTRIC PORT LEAK THAT CAUSED SKIN BREAKDOWN AROUND STOMA SITE, STOMA SITE WAS CLEANSED WITH SOAP AND WATER AND TREATED WITH ZINC OXIDE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1803092 MIC-KEY LOW-PROFILE GASTROSTOMY FEEDING TUBE DH EF BALLOON TUBES PRODUCTS KNT AVANOS MEDICAL INC. 0120-14-2.5 30226992 00350770948478

    Patients

    Seq Age Sex Outcome Treatment
    1 17 YR Male Other