BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MIC-KEY GASTROSTOMY FEEDING TUBE KIT (ENFIT)

    MDR report key: 19862283 · Received July 30, 2024

    Report

    Report Number
    9611594-2024-00142
    Event Type
    Injury
    Date Received
    July 30, 2024
    Date of Event
    June 19, 2024
    Report Date
    July 23, 2025
    Manufacturer
    AVANOS MEDICAL INC.
    Product Code
    KNT
    UDI-DI
    00350770427270
    PMA / PMN Number
    K043114
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    A REVIEW OF THE DEVICE HISTORY RECORD AND UDI ARE IN-PROGRESS. THE PRODUCT INVOLVED IN THE REPORT HAS BEEN RETURNED AND THE INVESTIGATION REMAINS IN PROGRESS AT THIS TIME. ALL INFORMATION REASONABLY KNOWN AS OF (B)(6) 2024 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 SAMPLE IS REPORTED TO BE AVAILABLE BUT HAS NOT YET BEEN RECEIVED BY THE MANUFACTURER. A REVIEW OF THE DEVICE HISTORY RECORD IS NOT POSSIBLE AS NO LOT NUMBER WAS PROVIDED; THEREFORE, THE UDI-PI IS UNAVAILABLE. ALL INFORMATION REASONABLY KNOWN AS OF 29 JUL 2024 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

    ADDITIONAL INFORMATION: THE DEVICE HISTORY RECORD FOR LOT 30148919 WAS REVIEWED AND THE PRODUCT WAS PRODUCED ACCORDING TO PRODUCT SPECIFICATIONS. THE ACTUAL COMPLAINT PRODUCT WAS RETURNED FOR EVALUATION. SUBJECT SAMPLE PROVIDED WAS EVALUATED, THERE WERE CRUSTY AND BROWNISH FOREIGN MATERIAL PRESENT. THIS IS A NON-PRODUCTION RELATED INCIDENT. ACCORDING TO COMPLAINT COMMENTS, SINCE THE DEVICE WAS IN USE FOR AN EXTENDED PERIOD OF TIME WITHIN 90+ DAYS, WHICH, INDICATES THAT DEVICE DID NOT SHOW THIS DEFECT AT TIME OF PLACEMENT AND THE TUBE PERFORMED AS INTENDED. A ROOT CAUSE COULD NOT BE DETERMINED. ALL INFORMATION REASONABLY KNOWN AS OF 22 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, GASTRONOMY SITE LEAKING AND SURROUNDING SKIN RED. PATIENT DEVELOPED GRANULOMA. SMALL MUSHROOM TYPE GROWTH ON SHAFT. CHILD WELL IN HERSELF. NO PYREXIA, VOMITING OR OTHER SYMPTOMS. DEVICE ORIGINALLY PLACED IN HOSPITAL. CHANGED EVERY 4 MONTHS BY PARENTS. PER ADDITIONAL INFORMATION RECEIVED ON 02JUL2024, THE DEVICE WAS REPORTED AS PLACED IN (B)(6), THE PROBLEM WAS NOTICED ON (B)(6) 2024 AND WAS SUBSEQUENTLY REMOVED ON (B)(6) 2024. PER ADDITIONAL INFORMATION RECEIVED ON 03JUL2024, ¿THE SKIN SWAB GREW LIGHT GROWTH OF YEAST AND MODERATE GROWTH OF STAPHYLOCOCCUS AUREUS. PRELIMINARY RESULT SHOWS THE ASPIRATE HAS GROWN YEASTS. GRAM NEGATIVE BACILLI. CULTURE MIXED GROWTH INCLUDING HEAVY GROWTH OF CANDIDA ALBICANS. ONE OF OUR PAEDIATRIC CONSULTANTS PRESCRIBED APPROPRIATE TREATMENT, BOTH TOPICAL AND SYSTEMIC. THE PATIENT IS WELL IN HERSELF.¿.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    245210 MIC-KEY GASTROSTOMY FEEDING TUBE KIT (ENFIT) DH EF BALLOON TUBES PRODUCTS KNT AVANOS MEDICAL INC. 8140-14-1.5 30148919 00350770427270

    Patients

    Seq Age Sex Outcome Treatment
    1 13 YR Female Required Intervention