BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MIC-KEY GASTROSTOMY FEEDING TUBE EXTENSION SETS WITH ENFIT CONNECTOR

    MDR report key: 10388073 · Received August 10, 2020

    Report

    Report Number
    9611594-2020-00147
    Event Type
    Malfunction
    Date Received
    August 10, 2020
    Report Date
    August 27, 2020
    Manufacturer
    AVANOS MEDICAL INC.
    Product Code
    KNT
    UDI-DI
    00350770427454
    PMA / PMN Number
    K043114
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    ALL INFORMATION REASONABLY KNOWN AS OF 27 AUG 2020 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 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 · 1

    THE ACTUAL COMPLAINT PRODUCT WAS NOT RETURNED FOR EVALUATION. ROOT CAUSE COULD NOT BE DETERMINED. A REVIEW OF THE DEVICE HISTORY RECORD IS NOT POSSIBLE AS NO LOT NUMBER WAS PROVIDED. ALL INFORMATION REASONABLY KNOWN AS OF 10 AUG 2020 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. 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 COMPLAINT DATABASE AND IDENTIFIED AS COMPLAINT (B)(4).

    Description of Event or Problem · 1

    AVANOS MEDICAL INC. RECEIVED A SINGLE REPORT THAT REFERENCED FOUR DIFFERENT INCIDENCES, WHICH WERE ASSOCIATED WITH THE SAME UNIT, INVOLVING THE SAME PATIENT. THIS IS THE THIRD OF FOUR REPORTS. REFER TO 9611594-2020-00145 FOR THE FIRST REPORT. REFER TO 9611594-2020-00146 FOR THE SECOND REPORT. REFER TO 9611594-2020-00148 FOR THE FOURTH REPORT. IT WAS REPORTED TO THE HOSPITAL BY THE PATIENT'S FAMILY THAT THE OVERNIGHT FEED EXTENSION TUBING HAD DISCONNECTED FROM THE MIC KEY FEEDING TUBE. THIS EVENT OCCURRED BETWEEN (B)(6) 2020. THE PATIENT WAS RECEIVING CONTINUOUS FEED AT NIGHT DUE TO A GLYCOGEN STORAGE DISEASE TYPE 1A, AND HAD BEEN HOSPITALIZED STARTING ON (B)(6) 2020 DUE TO HYPOGLYCEMIA AND SEIZURE RELATED TO THAT CONDITION. THE TUBE HAD BEEN PLACED ON (B)(6) 2020. THERE WAS NO INJURY TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    850687 MIC-KEY GASTROSTOMY FEEDING TUBE EXTENSION SETS WITH ENFIT CONNECTOR DH EF BALLOON TUBES PRODUCTS KNT AVANOS MEDICAL INC. 8140-16-1.7 UNKNOWN 00350770427454

    Patients

    Seq Age Sex Outcome Treatment
    1 10 MO