BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MIC GASTROSTOMY FEEDING TUBE WITH ENFIT CONNECTOR

    MDR report key: 10036732 · Received May 7, 2020

    Report

    Report Number
    9611594-2020-00077
    Event Type
    Malfunction
    Date Received
    May 7, 2020
    Date of Event
    March 4, 2020
    Report Date
    August 21, 2020
    Manufacturer
    AVANOS MEDICAL INC.
    Product Code
    KNT
    PMA / PMN Number
    K842076
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    A PHOTO OF THE DEVICE WAS PROVIDED BY THE DISTRIBUTOR. SUBJECT PHOTO SHOWED THAT THE ACCESS PORT PLUG STRAP WAS CUT. NO MANUFACTURING ACTIVITY WAS IDENTIFIED THAT COULD HAVE CONTRIBUTED TO THIS ISSUE. ROOT CAUSE COULD NOT BE DETERMINED. ALL INFORMATION REASONABLY KNOWN AS OF 21 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 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.

    Additional Manufacturer Narrative · 0

    THE DEVICE HISTORY RECORD FOR LOT AA9056D26 WAS REVIEWED AND THE PRODUCT WAS PRODUCED ACCORDING TO PRODUCT SPECIFICATIONS. THE ACTUAL COMPLAINT PRODUCT WAS NOT RETURNED FOR EVALUATION. ROOT CAUSE COULD NOT BE DETERMINED. ALL INFORMATION REASONABLY KNOWN AS OF (B)(6)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 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.

    Additional Manufacturer Narrative · 1

    A REVIEW OF THE DEVICE HISTORY RECORD IS IN-PROGRESS. ALL INFORMATION REASONABLY KNOWN AS OF 06 MAY 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 INC. COMPLAINT DATABASE AND IDENTIFIED AS COMPLAINT (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT "THE PROBE IS INSERTED ENDOSCOPICALLY ON (B)(6) 2020 AND HAS AN EXPECTED SHELF LIFE OF UP TO 6 MONTHS. ON (B)(6) 2020, THE PROBE IS DEFECTIVE IN THE ENFIT SOCKET AS THE RECOVERY IS BROKEN OFF. THIS MEANS THAT THE PROBE MUST BE CHANGED (NOT ENDOSCOPICALLY) DUE TO LEAKAGE. THE PROBE WAS CHANGED BY A NURSE AT THE HOSPITAL WHEN THE STOMA WAS LESS THAN A MONTH OLD." "THE PROBE HAS NOT BEEN ABLE TO BE USED PROPERLY, WHICH IS WHY PT. [PATIENT] HAD TO BE BROUGHT TO HOSPITAL TO HAVE THE PROBE CHANGED." NO PATIENT INJURY WAS REPORTED. ADDITIONAL INFORMATION RECEIVED 01-MAY-2020 INDICATED THAT "THE DEVICE IS USED FOR CONTINUOUS FEED IN ORDER TO MAINTAIN LIFE." FURTHER ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT NOT YET RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    499289 MIC GASTROSTOMY FEEDING TUBE WITH ENFIT CONNECTOR DH EF BALLOON TUBE PRODUCTS KNT AVANOS MEDICAL INC. 8100-16LV AA9056D26

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR