BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MIC-KEY GASTRIC-JEJUNAL FEEDING TUBE KIT (ENFIT)

    MDR report key: 18369759 · Received December 20, 2023

    Report

    Report Number
    9611594-2023-00183
    Event Type
    Malfunction
    Date Received
    December 20, 2023
    Report Date
    March 6, 2024
    Manufacturer
    AVANOS MEDICAL INC.
    Product Code
    KNT
    UDI-DI
    00350770440927
    PMA / PMN Number
    K922667
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION: H6, H10. H6: INVESTIGATION FINDINGS: APPROPRIATE TERM/CODE NOT AVAILABLE: MALFUNCTION OBSERVED WITHOUT CONCLUSIVE FINDING THE DEVICE HISTORY RECORD FOR LOT 30181855 WAS REVIEWED AND THE PRODUCT WAS PRODUCED ACCORDING TO PRODUCT SPECIFICATIONS. THE TUBING WAS THEN EXAMINED UNDER MAGNIFICATION. THERE IS A TEAR OF THE OUTER WALL BETWEEN THE GASTRIC SKIVES. WITH CLOSE INSPECTION, IT WAS FOUND THAT THE INNER SEPTUM WHICH SEPARATES THE GASTRIC AND JEJUNAL LUMENS IS ALSO TORN OR RUPTURED. FEEDING WAS SIMULATED USING WATER. WHEN FED THROUGH THE GASTRIC PORT, THE WATER EXITED THE GASTRIC SKIVES. WHEN FED THROUGH THE JEJUNAL PORT, THE WATER EXITED THROUGH THE DAMAGED SEPTUM AND GASTRIC SKIVES. IT DID NOT FLOW DOWN TO THE JEJUNAL SKIVES AT THE DISTAL END. THE INCIDENT WAS CONFIRMED BASED ON SAMPLE EVALUATION. A ROOT CAUSE COULD NOT BE DETERMINED. ALL INFORMATION REASONABLY KNOWN AS OF 06 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.

    Additional Manufacturer Narrative · 0

    THIS EVENT WAS DEEMED REPORTABLE DURING SAMPLE EVALUATION ON REGULATORY ALERT DATE 30NOV2023. THE DEVICE HISTORY RECORD FOR LOT 30181855 WAS REVIEWED AND THE PRODUCT WAS PRODUCED ACCORDING TO PRODUCT SPECIFICATIONS. THE PRODUCT INVOLVED IN THE REPORT HAS BEEN RETURNED AND THE INVESTIGATION REMAINS IN PROGRESS AT THIS TIME. ALL INFORMATION REASONABLY KNOWN AS OF 19 DEC 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 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 INITIALLY REPORTED, THE FEEDING TUBE SPLIT [IN AN UNKNOWN LOCATION] WHEN THE PARENT WAS ATTEMPTING TO UNCLOG THE TUBE WITH COCA COLA. A NEW TUBE WAS [REPORTEDLY] PLACED AT HOME. NO INJURY REPORTED. PER SAMPLE EVALUATION COMPLETION ON REGULATORY ALERT DATE 30NOV2023, THE SAMPLE EVALUATION OBSERVED THE FAILURE TO ALLOW FOR CROSS-COMMUNICATION BETWEEN THE GASTRIC AND JEJUNAL FEED LUMENS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2051749 MIC-KEY GASTRIC-JEJUNAL FEEDING TUBE KIT (ENFIT) DH EF BALLOON TUBES PRODUCTS KNT AVANOS MEDICAL INC. 8270-16-2.0-30 30181855 00350770440927

    Patients

    Seq Age Sex Outcome Treatment
    1 7 YR Female