BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CORTRAK 2 ENTERAL ACCESS SYSTEM

    MDR report key: 15060414 · Received July 19, 2022

    Report

    Report Number
    3011270181-2022-00052
    Event Type
    Injury
    Date Received
    July 19, 2022
    Date of Event
    June 6, 2022
    Report Date
    May 23, 2024
    Manufacturer
    AVANOS MEDICAL INC.
    Product Code
    KNT
    UDI-DI
    00350770472010
    PMA / PMN Number
    K220588
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE ACTUAL COMPLAINT PRODUCT WAS NOT RETURNED FOR EVALUATION. A REVIEW OF THE DEVICE HISTORY RECORD IS NOT POSSIBLE AS NO LOT NUMBER WAS PROVIDED. ROOT CAUSE COULD NOT BE DETERMINED. 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 (DHR) FOR THE REPORTED LOT NUMBER, 20030081, IN THIS COMPLAINT WAS REVIEWED AND THE MATERIAL WAS PRODUCED ACCORDING TO THE MANUFACTURING PROCEDURES AND MET THE QUALITY REQUIREMENTS. A SAMPLE WAS NOT AVAILABLE FOR EVALUATION. HOWEVER, THE USER DID PROVIDE COPIES OF TRACINGS. AVANOS MEDICAL, INC REVIEWED THE PROVIDED TRACINGS AND NOTED THAT BOTH TRACINGS INDICATE DEVIATION INTO LEFT LUNG AREA AND BEST PRACTICES FOR USE OF CORTRAK EAS WERE NOT FOLLOWED. DUE TO THE DHR AND THE PROVIDED TRACINGS DID NOT FOLLOW TYPICAL PLACEMENT PATTERN AND SHOWED DEVIATION INTO THE LEFT LUNG AREA, THE ROOT CAUSE WAS DETERMINED TO BE "USER: INCORRECT USE". ALL INFORMATION REASONABLY KNOWN AS OF 26-AUG-2022 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. SHOW LESS.

    Additional Manufacturer Narrative · 0

    ALL INFORMATION REASONABLY KNOWN AS OF 23-MAY-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.

    Description of Event or Problem · 0

    IT WAS REPORTED VIA FDA MEDWATCH / FDA USER FACILITY REPORT # MW 5110241 THE FOLLOWING INFORMATION: PNEUMOTHORAX FOLLOWING ATTEMPTED CORTRAK FEEDING TUBE PLACEMENT USING MAGNETIC TRACKING SYSTEM. AVANOS CORTRAK-2 NASOGASTRIC /NASOINTESTINAL FEEDING TUBE WITH ELECTROMAGNETIC TRANSMITTING STYLET. ON (B)(6) 2022 2 UNSUCCESSFUL ATTEMPTS TO PLACE CORTRAK 2, USING MAGNETIC GUIDANCE. CHEST X-RAY (CXR) TO CHECK PLACEMENT, CXR CONFIRMED LEFT PNEUMOTHORAX REQUIRING CHEST TUBE PLACEMENT.

    Description of Event or Problem · 0

    EVENT DATE AND TIME: 06-JUN-2022 AT 1413. ADDITIONAL INFORMATION RECEIVED 01-AUG-2022 STATED THE PATIENT WAS NOT INTUBATED AT THE TIME OF TUBE. PLACEMENT. TUBE PLACEMENT WAS CONFIRMED VIA CHEST X-RAY. A CHEST TUBE WAS PLACED ON 06-JUN-2022 AT 1413.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    877116 CORTRAK 2 ENTERAL ACCESS SYSTEM DH CORTRAK (EAS) KNT AVANOS MEDICAL INC. 20-0950 UNKNOWN 00350770472010

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Male Other| R 40-9551TRAK2 NG/NI| RECEIVER UNIT NUMBER: 20030072