BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CORTRAK 2 ENTERAL ACCESS SYSTEM

    MDR report key: 12781876 · Received November 9, 2021

    Report

    Report Number
    3006646024-2021-00022
    Event Type
    Injury
    Date Received
    November 9, 2021
    Date of Event
    October 14, 2021
    Report Date
    May 24, 2024
    Manufacturer
    AVANOS MEDICAL INC.
    Product Code
    KNT
    UDI-DI
    00350770472010
    PMA / PMN Number
    K113351
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    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 · 0

    THE DEVICE HISTORY RECORD FOR THE REPORTED LOT NUMBER, 1908010, IN THIS COMPLAINT WAS REVIEWED AND THE MATERIAL WAS PRODUCED ACCORDING TO THE MANUFACTURING PROCEDURES AND MET THE QUALITY REQUIREMENTS. THE ACTUAL COMPLAINT PRODUCT WAS NOT RETURNED FOR EVALUATION. ALL INFORMATION REASONABLY KNOWN AS OF 09-NOV-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. 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 · 0

    IT WAS REPORTED DURING A NASOGASTRIC (NG) TUBE A LEFT LUNG PLACEMENT OCCURRED. THE PATIENT HAD A RECENT LUNG TRANSPLANT AND WAS INTUBATED BUT NOT SEDATED WITH AN ORAL-GASTRIC(OG) TUBE ADDITIONAL INFORMATION RECEIVED 19-NOV-2021 STATED THE PATIENT ALREADY HAD CHEST TUBE IN PLACE, A BRONCHOSCOPY WAS PERFORMED TO REMOVE THE CORTRAK NG TUBE. THE INCIDENT OCCURRED ON (B)(6) 2021 AT 10:02AM AND AS (B)(6) 2021 AT 11:00AM NO PNEUMOTHORAX WAS REPORTED. THE PATIENT REMAINED INTUBATED WITH THE OG TUBE. AN ABDOMINAL 1 VIEW X-RAY WAS PERFORMED ON (B)(6) 2021 AT 11:45AM. PER THE 'FINDINGS' SECTION OF THE X-RAY REPORT: THE TIP OF THE FEEDING TUBE IS OVER THE LEFT LOWER LUNG. NO PNEUMATOSIS. NO PNEUMOPERITONEUM. NO OVERT OBSTRUCTION. GROSSLY UNCHANGED LOWER CHEST. THERE WAS ALSO A CHEST X-RAY COMPLETED ON (B)(6) 2021 AT 12:00PM. THAT REPORT WAS AS FOLLOWS: STATUS POST LUNG TRANSPLANT. CORPAK TERMINATES IN THE LEFT LOWER BRONCHUS. STABLE CARDIOMEDIASTINAL SILHOUETTE. BIBASILAR ATELECTASIS. NO PNEUMOTHORAX OR PLEURAL EFFUSION. ON (B)(6) 2021 AT 12:35PM, ANOTHER CHEST X-RAY WAS PERFORMED STATING: CORPAK IS REMOVED. NO SIGNIFICANT INTERVAL CHANGE. A BEDSIDE BRONCHOSCOPY WAS PERFORMED ON (B)(6) 2021 AND THE PROCEDURE NOTE STATED THE FOLLOWING: YELLOW COLORED NJT [NASOJEJUNAL TUBE] NOTED TO BE PASSING ALONGSIDE OF THE ETT [ENDOTRACHEAL TUBE], IN THE TRACHEA, ACROSS THE LEFT ANASTOMOSIS AND IN TO THE LLL [LEFT LOWER LUNG]. WITHOUT ANY DIFFICULTY, WE WERE ABLE TO REMOVE THE NJT UNDER BRONCHOSCOPIC VISUALIZATION. ANASTOMOSIS: INTACT (PRE & POST NJT REMOVAL). NO BLEEDING OR TRAUMA NOTED POST REMOVAL. THERE WERE NO NEW UPDATES ON THE PATIENT AS OF WHEN THE NEW INFORMATION WAS RECEIVED ON 19-OCT-2021. THERE WAS NO SIGNIFICANT INTERVAL CHANGE NOTED ON (B)(6) POST FEEDING TUBE REMOVAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1681032 CORTRAK 2 ENTERAL ACCESS SYSTEM DH CORTRAK (EAS) KNT AVANOS MEDICAL INC. 20-0950 N/A 00350770472010

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Male (B)(6)