BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MIC-KEY GASTROSTOMY (G) FEEDING TUBE KITS

    MDR report key: 24621318 · Received March 17, 2026

    Report

    Report Number
    9611594-2026-00135
    Event Type
    Malfunction
    Date Received
    March 17, 2026
    Date of Event
    February 19, 2026
    Report Date
    May 15, 2026
    Manufacturer
    AVANOS MEDICAL INC.
    Product Code
    KNT
    UDI-DI
    00350770427317
    PMA / PMN Number
    K043114
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE SAMPLE IS REPORTED TO BE AVAILABLE BUT HAS NOT YET BEEN RECEIVED BY THE MANUFACTURER. A REVIEW OF THE DEVICE HISTORY RECORD IS IN-PROGRESS. ALL INFORMATION REASONABLY KNOWN AS OF 16 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 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, ¿THE CONSUMER REPORTS A BLOCKED BUTTON THAT NECESSITATED REPLACEMENT DURING THE NIGHT. THE CONSUMER'S BLOOD SUGAR LEVELS WERE IN THE HYPOGLYCEMIC RANGE, AND THE FEEDING PUMP CONTINUED TO OPERATE WITHOUT AN ALARM. THE FEEDING SOLUTION WAS OBSERVED TO BE LEAKING FROM THE SAFETY CONNECTOR NEXT TO THE BUTTON. BLOOD SUGAR LEVELS WERE MONITORED FROM 00:21 TO 4:57 A.M., WITH READINGS BETWEEN 28 MG AND 110 MG. AT 0:30 A.M., A 5 ML DOSE OF 40% GLUCOSE CONCENTRATE WAS ADMINISTERED ORALLY AS AN EMERGENCY MEASURE. SUBSEQUENTLY, THE CONSUMER RECEIVED HUMANA WITH RICE FLAKES VIA A NEW BUTTON AND STARCH ORALLY TO STABILIZE BLOOD SUGAR. AT 4:47 A.M., THE SAME PUMP WAS RECONNECTED AND OPERATED UNTIL 9:40 A.M. AT A RATE OF 50 ML/H. AN ATTEMPT TO FLUSH THE REMOVED, DEFECTIVE BUTTON WAS UNSUCCESSFUL. THE BUTTON WAS FLUSHED WITH WATER AFTER THE EVENING MEAL AT 6:00 P.M., AS IS CUSTOMARY, BEFORE CONNECTING THE PUMP FOR ITS SCHEDULED OVERNIGHT OPERATION. THE PUMP WILL NOT BE USED FOR THE TIME BEING, STARTING TONIGHT. THE FAMILY WILL USE A PUMP WITH SERIAL NUMBER: (B)(6). THE CONSUMER IS 2 YEARS OLD, MALE, WITH A DIAGNOSIS OF GLYCOGEN STORAGE DISEASE TYPE 1A. THE APPLICATION TECHNIQUE INVOLVES AN AVANOS BUTTON CH14 2.0 CM, PERCUTANEOUS, PUMP, STOMACH. THE LAST POSITION CHECK WAS ON (B)(6) 2026. THE TRANSFER DEVICE USED IS FLOCARE INFINITY BOTTLES/PACK WITHOUT A DRIP CHAMBER. A FUNCTIONAL TEST OF FLOCARE INFINITY 2 ON (B)(6) 2025 CONFIRMED CONTINUOUS DRIP AT 50 ML/H OVERNIGHT WITH NO ERROR MESSAGES.¿

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    624958 MIC-KEY GASTROSTOMY (G) FEEDING TUBE KITS DH EF BALLOON TUBES PRODUCTS KNT AVANOS MEDICAL INC. 8140-14-2.0 30368879 00350770427317

    Patients

    Seq Age Sex Outcome Treatment
    1 24 MO Male Other FLOCARE INFINITY BOTTLES/PACK.