BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MIC GASTROSTOMY FEEDING TUBE WITH ENFIT CONNECTORS - 14 FR

    MDR report key: 20750340 · Received November 21, 2024

    Report

    Report Number
    9611594-2024-00265
    Event Type
    Malfunction
    Date Received
    November 21, 2024
    Date of Event
    September 24, 2024
    Report Date
    January 7, 2025
    Manufacturer
    AVANOS MEDICAL INC.
    Product Code
    KNT
    UDI-DI
    00350770442914
    PMA / PMN Number
    K842076
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    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 AND UDI NUMBER ARE IN-PROGRESS. ALL INFORMATION REASONABLY KNOWN AS OF 20-NOV-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 EVENT REPORTED BUT IS RELAYING THE INFORMATION THAT WAS PROVIDED BY THE USER FACILITY WHERE THE INCIDENT OCCURRED. THIS PRODUCT INCIDENT IS DOCUMENTED IN THE AVANOS MEDICAL, INC. COMPLAINT DATABASE AND IDENTIFIED AS COMPLAINT COMP (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 DEVICE HISTORY RECORD FOR THE REPORTED LOT NUMBER, 30238598, IN THIS COMPLAINT WAS REVIEWED AND THE MATERIAL WAS PRODUCED ACCORDING TO THE MANUFACTURING PROCEDURES AND MET THE QUALITY REQUIREMENTS. ALL INFORMATION REASONABLY KNOWN AS OF 06-JAN-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 EVENT REPORTED BUT IS RELAYING THE INFORMATION THAT WAS PROVIDED BY THE USER FACILITY WHERE THE INCIDENT OCCURRED. THIS PRODUCT INCIDENT IS DOCUMENTED IN THE AVANOS MEDICAL, INC. 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 ENTERAL FEEDING "TUBE OPENED ONE NIGHT, CAUSING A LEAK OF GASTRIC FLUID. THIS RESULTED IN A SECOND-DEGREE BURN AND SUBSEQUENT WOUND INFECTION...THIS RESULTED IN A SECOND-DEGREE BURN AND SUBSEQUENT WOUND INFECTION." ADDITIONAL INFORMATION RECEIVED 28-OCT-2024 STATED MEDICAL INTERVENTION INCLUDED "ANTIBIOTIC THERAPY WITH AMOXICILLIN 3X1G/D FROM (B)(6)2024, ANALGESIA WITH PARACETAMOL SINCE (B)(6)2024, LOCAL TREATMENT WITH FLAMMAZINE CREAM FROM (B)(6)2024." THE CURRENT CONDITION OF THE PATIENT IS, "EVER-PRESENT WOUNDS, DAILY DRESSINGS FOR OOZING AND SMELLY WOUNDS."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1630922 MIC GASTROSTOMY FEEDING TUBE WITH ENFIT CONNECTORS - 14 FR DH EF BALLOON TUBES PRODUCTS KNT AVANOS MEDICAL INC. 8100-14LV 30238598 00350770442914

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Female Required Intervention| O