BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CORTRAK 2 ENTERAL ACCESS SYSTEM

    MDR report key: 9089114 · Received September 19, 2019

    Report

    Report Number
    3006646024-2019-00018
    Event Type
    Injury
    Date Received
    September 19, 2019
    Date of Event
    August 10, 2019
    Report Date
    January 19, 2020
    Manufacturer
    AVANOS MEDICAL INC.
    Product Code
    KNT
    UDI-DI
    00350770472010
    PMA / PMN Number
    K113351
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 0

    CORRECTION: THE FOLLOW-UP NUMBER TWO FOR REPORT NUMBER 3006646024-2019-00018, WHICH IS ALIGNED WITH (B)(4), WAS SUBMITTED AS A FOLLOW-UP NUMBER TWO REPORT FOR REPORT NUMBER 3006646024-2019-00019; WHICH IS ALIGNED WITH COMPLAINT (B)(4). THIS MEDWATCH A CORRECTION AND RESUBMISSION FOR FOLLOW-UP NUMBER TWO FOR REPORT NUMBER 3006646024-2019-00018. THE DEVICE HISTORY RECORD FOR THE REPORTED LOT NUMBER, 1203008, IN THIS COMPLAINT WAS REVIEWED AND THE MATERIAL WAS PRODUCED ACCORDING TO THE MANUFACTURING PROCEDURES AND MET THE QUALITY REQUIREMENTS. ALL INFORMATION REASONABLY KNOWN AS OF 17-JAN-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. SHOW LESS

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION: B5, B6, G3 AND H6 ALL INFORMATION REASONABLY KNOWN AS OF 24-OCT-2019 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. - ATTACHMENT: [MW 5089760.PDF]

    Description of Event or Problem · 0

    ADDITIONAL INFORMATION RECEIVED 27-SEP-2019 VIA FDA MEDWATCH/FDA USER FACILITY #5089760 STATING:"POST PYLORIC FEEDING TUBE PLACED WITH CORTRAK DEVICE INTO LEFT LUNG MD NOTIFIED, CXR 3 DAYS LATER SHOWED 25-30% PNEUMOTHORAX WHICH REQUIRED CHEST TUBE TO RESOLVE, 1308 FEEDING TUBE COULD BE WITHIN DISTAL ESOPHAGUS OR LUNG, FEEDING TUBE WITHDRAWAL AND REPLACEMENT IS RECOMMENDED, 1516 KUB KEOFEED PROBABLY IN PROXIMAL STOMACH, 1558 CXR FEEDING TUBE APPEARS TO EXTEND INTO LEFT MAINSTEM BRONCHUS AND APPEARS TO BE IN THE LEFT HEMITHORAX POSSIBLY IN PLEURAL SPACE, HOWEVER, NO LEFT PLEURAL EFFUSION OR PNEUMOTHORAX IS SEEN F/U CXR WITHIN ONE HOUR IS SUGGESTED ON (B)(6), 0400 LEFT SIDE PNEUMOTHORAX APPROXIMATED AT LEAST 25-30%, 1647 INTERVAL DECREASE IN SIZE OF LEFT PNEUMOTHORAX FOLLOWING PLACEMENT OF SMALL BORE LEFT CHEST TUBE, ON (B)(6) 1323 NEAR COMPLETE FULL EXPANSION WITH LESS THAN 5% PNEUMO ON (B)(6) 1624 NO IDENTIFIABLE PNEUMOTHORAX IS PRESENT."

    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 19-SEP-2019 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 (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THERE WAS A LUNG PLACEMENT FOLLOWING NASOGASTRIC (NGT) PLACEMENT. THE PLACEMENT WAS CONFIRMED VIA X-RAY AND THE NG TUBE WAS REMOVED. ADDITIONAL INFORMATION RECEIVED 27-AUG-2019 STATED THE DEVICE WAS PLACED AT 12:52PM. THE LUNG PLACEMENT EVENT OCCURRED IN THE LEFT LUNG. AN X-RAY EXAMINATION REVEALED A LUNG PLACEMENT OF THE DEVICE AND THE NG TUBE WAS REMOVED. SEVERAL DAYS LATER IT WAS DETERMINED THAT THE NG TUBE HAD PUNCTURED THE LUNG; A FOLLOW-UP X-RAY WAS NOT PERFORMED AFTER THE NG TUBE WAS REMOVED. ADDITIONAL INFORMATION RECEIVED 29-AUG-2019 STATED THE PATIENT WAS EXHIBITING SHORTNESS OF BREATH (SOB). A FOLLOW-UP, X-RAY REVEALED A 25% PNEUMOTHORAX IN THE LEFT LUNG. A CHEST TUBE PLACED (B)(6) 2019 AT 9:00AM. THE PATIENT WAS EVENTUALLY DISCHARGED HOME AT A LATER DATE, (B)(6) 2019.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    883659 CORTRAK 2 ENTERAL ACCESS SYSTEM DH CORTRAK (EAS) KNT AVANOS MEDICAL INC. 20-0950 1203008 00350770472010

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Required Intervention