BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CORTRAK 2 ENTERAL ACCESS SYSTEM

    MDR report key: 9896810 · Received March 30, 2020

    Report

    Report Number
    3011270181-2020-00052
    Event Type
    Injury
    Date Received
    March 30, 2020
    Date of Event
    February 13, 2020
    Report Date
    May 24, 2024
    Manufacturer
    AVANOS MEDICAL INC.
    Product Code
    KNT
    UDI-DI
    10680651472011
    PMA / PMN Number
    K113351
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NV, US
    Reporter Occupation
    BIOMEDICAL ENGINEER
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE HISTORY RECORD FOR THE REPORTED SERIAL NUMBER, 1611003, IN THIS COMPLAINT WAS REVIEWED AND THE DEVICE WAS PRODUCED ACCORDING TO THE MANUFACTURING PROCEDURES AND MET THE QUALITY REQUIREMENTS. ALL INFORMATION REASONABLY KNOWN AS OF 08-JUN-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

    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

    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 IN-PROGRESS. ALL INFORMATION REASONABLY KNOWN AS OF 28-MAR-2020 HAS BEEN INCLUDED IN THIS HEALTH AUTHORITY REPORT. SHOULD ADDITIONAL INFORMATION BE OBTAINED, A FOLLOW-UP HEALTH AUTHORITY REPORT WILL BE PROVIDED. 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 · 1

    IT WAS REPORTED THE CORTRAK DEVICE WAS USED FOR A NASOGASTRIC TUBE PLACEMENT ON (B)(6) 2020 AT 1130. THE PATIENT WAS ON A PULSE OXIMETER AND APPEARED STABLE. HE HAD A CONGESTED INTERMITTENT COUGH PRIOR TO THE PROCEDURE AND IT CONTINUED DURING THE PROCEDURE, WHICH WAS EXPECTED. THE PATIENT SWALLOWED AS HE WAS INSTRUCTED TO DO SO. THE PATIENT'S FULL COOPERATION WAS LIMITED BY CONFUSION. THE PATIENT'S OXYGEN SATURATIONS DROPPED TO 70% (ALSO EXPECTED) DURING THE PROCEDURE BUT RESOLVED WHEN THE CORTRAK TUBE WAS BRIDLED. AT 1230, THE RADIOLOGIST NOTED THE CORTRAK TUBE WAS MISPLACED IN THE LEFT PLEURAL SPACE VIA POTENTIAL LUNG PUNCTURE. THE PATIENT WAS STILL STABLE AND HIS PULSE OXIMETRY WAS CIRCA 90%. THE CORTRAK TUBE WAS REMOVED. THE PATIENT VERBALIZED AN IMPROVED ABILITY TO SPEAK. AT 1300 A FOLLOW-UP CHEST X-RAY SHOWED A PNEUMOTHORAX. AT 1800 THE PATIENT'S OXYGEN LEVEL DESATURATED TO 80% ON 5/LITERS OF OXYGEN VIA NASAL CANNULA. THE NURSE AND RESPIRATORY THERAPIST SWITCHED THE PATIENT TO 40% OXYGEN (8/LITERS) PER VENTI MASK. THE CHEST X-RAY WAS STABLE. ON (B)(6) 2020 AT 1314 THE CORTRAK IMPRESSION NOTED: MALPOSITIONED FEEDING TUBE EXTENDING INTO THE LEFT HEMITHORAX CONCERNING FOR LUNG PERFORATION WITH TUBE TIP IN THE POSTERIOR SULCUS PLEURAL SPACE. THE DEVICE WAS REMOVED AND NO SPECIFIC MEDICAL INTERVENTION WAS PERFORMED. ADDITIONAL INFORMATION RECEIVED 06-MAR-2020 STATED NO TREATMENT WAS REQUIRED. A CHEST X-RAY WAS PERFORMED AND NOTED A SMALL PNEUMOTHORAX THAT DID NOT REQUIRE A CHEST TUBE OR OTHER INTERVENTION. THE PATIENT DIED A FEW DAYS AFTER THIS INCIDENT FROM HIS PRIMARY DIAGNOSIS (NOT RELATED TO THE NASOGASTRIC TUBE INCIDENT). ADDITIONAL INFORMATION RECEIVED 13-MAR-2020 FROM THE USER STATED, "REGRETTABLY, WE WILL NOT BE RELEASING DETAILS SURROUNDING THE DEATH SINCE IT WAS NOT RELATED TO THE DEVICE IN QUESTION."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    359788 CORTRAK 2 ENTERAL ACCESS SYSTEM DH CORTRAK (EAS) KNT AVANOS MEDICAL INC. 20-0950 N/A 10680651472011

    Patients

    Seq Age Sex Outcome Treatment
    1 94 YR Male Life Threatening| O| D OXYGEN