BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MIC JEJUNAL FEEDING TUBE WITH ENFIT CONNECTOR

    MDR report key: 24183230 · Received January 26, 2026

    Report

    Report Number
    9611594-2026-00021
    Event Type
    Injury
    Date Received
    January 26, 2026
    Report Date
    January 26, 2026
    Manufacturer
    AVANOS MEDICAL INC.
    Product Code
    KNT
    UDI-DI
    00350770445663
    PMA / PMN Number
    K853197
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE ACTUAL COMPLAINT PRODUCT WAS NOT RETURNED FOR EVALUATION. A REVIEW OF THE DEVICE HISTORY RECORD IS NOT POSSIBLE AS NO LOT NUMBER WAS PROVIDED; THEREFORE, THE UDI-PI IS UNAVAILABLE. A ROOT CAUSE COULD NOT BE DETERMINED. ALL INFORMATION REASONABLY KNOWN AS OF 26 JAN 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, "74-YEAR-OLD FEMALE PATIENT ADMITTED TO INTENSIVE CARE FOR INHALATION PNEUMONIA. JEJUNOSTOMY TUBE INSERTED ON (B)(6) 2025. COMPRESSION POINT OBSERVED ON THE TUBE, REQUIRING DEFLATION OF THE BALLOON WITH LEAKAGE OF FOOD AND DIGESTIVE FLUID AROUND THE PERIMETER AND REMOVAL OF THE FIXATION SUTURES TO INSERT A PROTECTIVE DRESSING PLATE WITH A HIGH RISK OF ACCIDENTAL REMOVAL IN A CONFUSED AND AGITATED INTENSIVE CARE PATIENT. ANTIBIOTIC THERAPY, LOCAL CARE, RISK OF NECROSIS/ABDOMINAL WALL ABSCESS AND REPEAT SURGERY. MEDICAL OR SURGICAL INTERVENTION: PURULENT DISCHARGE SUGGESTING SUPPURATIVE DERMOHYPODERMITIS OF THE ABDOMINAL WALL, REQUIRING MORPHINE TITRATION TO CONTROL PAIN, CAUSING CONFUSION."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    238664 MIC JEJUNAL FEEDING TUBE WITH ENFIT CONNECTOR DH EF BALLOON TUBES PRODUCTS KNT AVANOS MEDICAL INC. 8200-12LV UNKNOWN 00350770445663

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Female Other