BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MIC-KEY LOW-PROFILE GASTROSTOMY FEEDING TUBE WITH SECUR-LOK

    MDR report key: 16976429 · Received May 22, 2023

    Report

    Report Number
    9611594-2023-00063
    Event Type
    Injury
    Date Received
    May 22, 2023
    Report Date
    August 15, 2023
    Manufacturer
    AVANOS MEDICAL INC.
    Product Code
    KNT
    UDI-DI
    00350770948324
    PMA / PMN Number
    K043114
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    A REVIEW OF THE DEVICE HISTORY RECORD IS 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 10 JUL 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.

    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. ALL INFORMATION REASONABLY KNOWN AS OF 16 MAY 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. H3 OTHER TEXT : DEVICE NOT RETURNED.

    Additional Manufacturer Narrative · 0

    THE DEVICE HISTORY RECORD FOR LOT 30186149 WAS REVIEWED AND THE PRODUCT WAS PRODUCED ACCORDING TO PRODUCT SPECIFICATIONS. THE ACTUAL COMPLAINT PRODUCT WAS RETURNED FOR EVALUATION. THE FEED PORT WAS EXAMINED UNDER MAGNIFICATION. NO VISIBLE DRIED MATTER WAS OBSERVED INSIDE THE FEED PORT OR IN THE DUCKBILL VALVE (DBV) SLIT. THERE ARE NO TEARS OR CUTS OBSERVED ON THE SILICONE DBV. THE SLIT DOES NOT HAVE AN OPEN SET. WATER WAS INFUSED, USING GRAVITY, INTO THE FEED LUMEN FROM THE DISTAL END. WITHOUT APPLIED PRESSURE (GRAVITY), LEAKAGE WAS NOT OBSERVED. BACK PRESSURE WAS APPLIED. PRESSURIZATION WAS PERFORMED BY HAND. WITH SLIGHT APPLIED PRESSURE, LEAKAGE OCCURRED FROM THE BOND BETWEEN THE FEED PORT AND MOLDED HEAD, ADJACENT TO THE STRAP. THE AREA WAS EXAMINED, AND A SEPARATION OF THE BOND WAS OBSERVED. BASED ON THE SAMPLE EVALUATION, THE INCIDENT WAS CONFIRMED. HOWEVER, A ROOT CAUSE COULD NOT BE DETERMINED. ALL INFORMATION REASONABLY KNOWN AS OF 09 AUG 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 REPORTED THAT THE FEEDING TUBES LEAKED FROM THE GASTRIC PORT AND CAUSED STOMA IRRITATION AND INFECTION ON THE SKIN AROUND THE STOMA. PER ADDITIONAL INFORMATION RECEIVED ON 26APR2023, THE CUSTOMER HAS BEEN STRUGGLING WITH THIS FOR A YEAR AND HAD TO USE ANTIBIOTICS FOR A LONG PERIOD OF TIME. PER ADDITIONAL INFORMATION RECEIVED ON 11MAY2023, ¿WE USED FUCIDIN ANTIBIOTICS CREAM. AND HAD TO DO SALINE SOAKS THREE TIMES A DAY FOR A LONG PERIOD OF TIME.¿

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    780263 MIC-KEY LOW-PROFILE GASTROSTOMY FEEDING TUBE WITH SECUR-LOK DH EF BALLOON TUBES PRODUCTS KNT AVANOS MEDICAL INC. 0120-12-2.0 30186149 00350770948324

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other FUCIDIN