BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CORTRAK2 NG/NI FEEDING TUBE W/ELECTROMAG TRANSMITTING STYLET W/ ENFIT CONNECTOR

    MDR report key: 12386059 · Received August 30, 2021

    Report

    Report Number
    9611594-2021-00115
    Event Type
    Malfunction
    Date Received
    August 30, 2021
    Date of Event
    August 8, 2021
    Report Date
    September 24, 2021
    Manufacturer
    AVANOS MEDICAL INC.
    Product Code
    KNT
    UDI-DI
    00350770460475
    PMA / PMN Number
    K821906
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 0

    THE PRODUCT INVOLVED IN THE REPORT HAS BEEN RETURNED AND IS BEING PROCESSED FOR EVALUATION. ALL INFORMATION REASONABLY KNOWN AS OF 13 SEP 2021 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 COMP-GHC-21-02508. 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

    ONE USED SAMPLE WAS RETURNED FOR EVALUATION. VISUAL EXAMINATION OF THE SAMPLE REVEALED DISCOLORATION AND DAMAGE. DURING DECONTAMINATION, A BROWNISH SUBSTANCE WAS FLUSHED FROM THE TUBING. A SPLIT/TEAR WAS NOTED AT THE 9CM MARKING. THE TUBING HAD EXPANDED INTO A BALLOON SHAPE, WHICH THEN BURST, CAUSING A SEPARATION OF THE TUBE INTO TWO PIECES. THE DISTAL END OF THE TUBE WAS NOT RETURNED. THE COMPLAINT IS CONFIRMED AS REPORTED. ROOT CAUSE COULD NOT BE CONCLUSIVELY DETERMINED, HOWEVER, IT IS LIKELY A USER RELATED PROBLEM SINCE AS PER THE INSTRUCTIONS FOR USE, VIGOROUS SYRINGE FORCE SHOULD NOT BE USED TO IRRIGATE, ADMINISTER LIQUIDS, OR UNBLOCK THE TUBE. ALL INFORMATION REASONABLY KNOWN AS OF 23 SEP 2021 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 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.

    Description of Event or Problem · 0

    PER ADDITIONAL INFORMATION RECEIVED 8 SEP 2021, THE FRAGMENT PASSED ON ITS OWN BUT WAS NOT RECOVERED. THE PATIENT IS "DOING FINE."

    Additional Manufacturer Narrative · 1

    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 27 AUG 2021 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT 10CM OF THE DISTAL END OF THE NASALGASTRIC (NG) TUBE BROKE OFF INSIDE THE PATIENT. PER X-RAY, THE PIECE IS INSIDE THE PATIENT'S INTESTINES AND THEY ARE WAITING FOR THE PIECE TO PASS NATURALLY. NO HARM TO THE PATIENT. PER ADDITIONAL INFORMATION RECEIVED ON 20 AUG 2021, THE TUBE WAS IN PLACE FOR 38 DAYS. THE TUBE WAS PLACED USING THE CORTRAK2 MONITOR SN CORTRAK MONITOR. NO FURTHER INFORMATION PROVIDED AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1280812 CORTRAK2 NG/NI FEEDING TUBE W/ELECTROMAG TRANSMITTING STYLET W/ ENFIT CONNECTOR DH CORTRAK DISPOSABLES KNT AVANOS MEDICAL INC. 40-9431TRAK2 UNKNOWN 00350770460475

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR CORTRAK2 MONITOR SN CORTRAK MONITOR