BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CORTRAK 2 NG/NI FEED TUBE, ELECTRO-STYLET WITH ENFIT

    MDR report key: 18833353 · Received March 4, 2024

    Report

    Report Number
    9611594-2024-00035
    Event Type
    Malfunction
    Date Received
    March 4, 2024
    Report Date
    April 1, 2024
    Manufacturer
    AVANOS MEDICAL INC.
    Product Code
    KNT
    UDI-DI
    00350770460475
    PMA / PMN Number
    K220588
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE ACTUAL SAMPLE WAS RECEIVED. THE RECEIVED SAMPLE WAS NOT RETURNED WITH THE ORIGINAL PACKAGING. THE DEVICE WAS EVALUATED CONFIRMING A SPLIT/TEAR IDENTIFIED WAS APPROXIMATELY AT THE 43CM MARKING, THE TUBING APPEARED TO HAVE EXPANDED TO FORM A BALLOON SHAPE WHICH BURST CAUSING A SEPARATION OF THE TUBE INTO TWO PIECES. THE LAYER OF THE BALLOONED PORTION OF TUBING OBSERVED TO BE THIN. BREAKING POINT WAS EXAMINED, NO UNKNOWN DRIED FOREIGN MATERIAL RESIDUE WAS OBSERVED. PER THE IFU (INSTRUCTIONS FOR USE), VIGOROUS SYRINGE FORCE SHOULD NOT BE USED TO IRRIGATE, ADMINISTER LIQUIDS, OR UNBLOCK THE TUBE. ROOT CAUSE COULD NOT BE DETERMINED. ALL INFORMATION REASONABLY KNOWN AS OF 01-APR-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(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 ACTUAL DEVICE IS REPORTED TO BE AVAILABLE BUT HAS NOT BEEN RETURNED FOR EVALUATION. A REVIEW OF THE DEVICE HISTORY RECORD IS NOT POSSIBLE AS NO LOT NUMBER WAS PROVIDED. ALL INFORMATION REASONABLY KNOWN AS OF 29-FEB-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 (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.

    Description of Event or Problem · 0

    IT WAS REPORTED THERE WAS A "BROKEN CORTRAK TUBE EVENT" DURING PATIENT USE. ADDITIONAL INFORMATION RECEIVED 07-FEB-2024 STATING THE TUBE WAS PLACED USING A CORTRAK EAS UNIT ON (B)(6) 2024, THE DEVICE WAS ADJUSTED ON (B)(6) 2024, NO LUNG PLACEMENT EVENT OCCURRED. TUBE FEED WAS ADMINISTERED THROUGH THIS TUBE. THERE WAS NO REPORTED INJURY AND NO MEDICAL INTERVENTION WAS REQUIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    196743 CORTRAK 2 NG/NI FEED TUBE, ELECTRO-STYLET WITH ENFIT DH CORTRAK DISPOSABLES KNT AVANOS MEDICAL INC. 40-9431TRAK2 UNKNOWN 00350770460475

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Male