BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MIC-KEY LOW-PROFILE GASTROSTOMY FEEDING TUBE - 18 FR, 2.7 CM

    MDR report key: 18049536 · Received November 1, 2023

    Report

    Report Number
    9611594-2023-00154
    Event Type
    Injury
    Date Received
    November 1, 2023
    Report Date
    March 21, 2024
    Manufacturer
    AVANOS MEDICAL INC.
    Product Code
    KNT
    UDI-DI
    00350770948881
    PMA / PMN Number
    K043114
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE ACTUAL COMPLAINT PRODUCT WAS NOT RETURNED FOR EVALUATION. A REVIEW OF THE DEVICE HISTORY RECORD IS IN-PROGRESS. ALL INFORMATION REASONABLY KNOWN AS OF 30 OCT 2023 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 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.

    Additional Manufacturer Narrative · 0

    CORRECTION: H4. ADDITIONAL INFORMATION: H10. THE DEVICE HISTORY RECORD FOR LOT 30209297 WAS REVIEWED AND THE PRODUCT WAS PRODUCED ACCORDING TO PRODUCT SPECIFICATIONS. A ROOT CAUSE COULD NOT BE DETERMINED. ALL INFORMATION REASONABLY KNOWN AS OF 19 MAR 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.

    Description of Event or Problem · 0

    IT WAS REPORTED, ¿SERIOUS REDNESS AND SKIN BURNING OCCURRED. A LAB CULTURE WAS TAKEN. CULTURE SHOWED MODERATE GROWTH OF YEAST CANDIDA. PACKAGING WAS VERIFIED INTACT. FILTERED WATER WAS USED 5.0ML. DUE TO THE SAMPLE BEING PROCESSED IN LAB IT WAS DISPOSED AS BIOHAZARDOUS UNDER SUSPICION OF BACTERIAL AND OR VIRAL CONTAMINATION. IT WAS HELD DURING THE TIME THE CULTURES WERE PROCESSING HOWEVER THE CULTURES WERE FINISHED AS OF THIS MORNING AND THE PHYSICIAN TEAM DID NOT CHECK THE ¿RETURN SAMPLES TO CLINIC¿ BOX ON THE LAB FORMS. THE SAMPLE CANNOT BE RETRIEVED HOWEVER THE LAB REPORT CAN BE PROVIDED. ANTIFUNGAL INTERVENTION WAS REQUIRED. NO HOSPITAL INVOLVEMENT OUTPATIENT CLINIC ¿ DERMATOLOGY. NYSTATIN 100,000U CREAM FOR 3 WEEKS TO THE PEG SITE TO ERADICATE ANY YEAST ORGANISMS. [THE PATIENT IS] STABLE CONDITION BEING MANAGED BY HOME INTERVENTION WITH TELEHEALTH SERVICING APPROX. WEEKLY.¿

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2032908 MIC-KEY LOW-PROFILE GASTROSTOMY FEEDING TUBE - 18 FR, 2.7 CM DH EF BALLOON TUBES PRODUCTS KNT AVANOS MEDICAL INC. 0120-18-2.7 30209297 00350770948881

    Patients

    Seq Age Sex Outcome Treatment
    1 32 YR Male Other NYSTATIN CREAM 100,000U X 3 WEEKS