BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CORTRAK ENTERAL ACCESS SYSTEM

    MDR report key: 17604535 · Received August 23, 2023

    Report

    Report Number
    3011270181-2023-00117
    Event Type
    Injury
    Date Received
    August 23, 2023
    Date of Event
    July 16, 2023
    Report Date
    January 9, 2024
    Manufacturer
    AVANOS MEDICAL INC.
    Product Code
    KNT
    UDI-DI
    00350770472010
    PMA / PMN Number
    K113351
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H6: INVESTIGATION FINDINGS: APPROPRIATE TERM/CODE NOT AVAILABLE: USAGE PROBLEM IDENTIFIED. THE DEVICE HISTORY RECORD FOR SERIAL NUMBER (B)(6) WAS REVIEWED AND THE PRODUCT WAS PRODUCED ACCORDING TO PRODUCT SPECIFICATIONS. THE CUSTOMER DID SEND IN A COPY OF THE TRACINGS OF THIS INCIDENT SO A CORVIEW CROSS-FUNCTIONAL REVIEW WAS COMPLETED. CORVIEW CROSS-FUNCTIONAL REVIEW NOTED THAT ALL TRACINGS PROVIDED DID NOT FOLLOW THE EXPECTED PATHWAY OF A TYPICAL GASTRIC PLACEMENT PATTERN WHEN REVIEWING THE MULTIPLE VIEWS TOGETHER. ADDITIONALLY, ALL TRACINGS EITHER INDICATED A DEVIATION INTO UPPER LEFT QUADRANT ON MONITOR UNIT SCREEN OR GREEN BALL HAD DIFFICULTY MOVING FORWARD. IMAGES OF THE OPTIMAL TRACING PATTERN (IN EACH VIEW) THAT SHOULD BE DISPLAYED ON THE MONITOR UNIT SCREEN ARE PROVIDED IN CORTRAK 2 EAS QUICK REFERENCE GUIDE, OPERATING AND TROUBLESHOOTING TIPS, AND OPERATOR¿S MANUAL. PER CORTRAK 2 EAS OPERATING AND TROUBLESHOOTING TIPS IFU, IF THE GREEN DOT IS NOT MOVING FORWARD, BUT THE OPERATOR IS INSERTING THE FEEDING TUBE: ¿RECOMMENDED ACTIONS: SLOWLY RETRACT THE FEEDING TUBE UNTIL THE GREEN DOT MOVES BACKWARD. THEN PROCEED WITH THE PLACEMENT PROCEDURE INTO THE SMALL BOWEL OR AS DIRECTED PER PHYSICIAN ORDER.¿ THE ROOT CAUSE WAS RELATED TO USER : INCORRECT USE. ALL INFORMATION REASONABLY KNOWN AS OF 05 OCT 2023 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 REPORTED EVENT BUT IS RELAYING THE INFORMATION PROVIDED BY THE USER FACILITY WHERE THE INCIDENT OCCURRED. THIS PRODUCT INCIDENT IS DOCUMENTED IN THE AVANOS MEDICAL 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

    CORTRAK MONITOR UNIT SOFTWARE RELEASE 2.5.4. A REVIEW OF THE DEVICE HISTORY RECORD IS IN-PROGRESS. ALL INFORMATION REASONABLY KNOWN AS OF 14 SEP 2023 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 REPORTED EVENT BUT IS RELAYING THE INFORMATION PROVIDED BY THE USER FACILITY WHERE THE INCIDENT OCCURRED. THIS PRODUCT INCIDENT IS DOCUMENTED IN THE AVANOS MEDICAL 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

    HEALTH EFFECT - CLINICAL CODE APPROPRIATE TERM / CODE NOT AVAILABLE: LUNG PLACEMENT / FEEDING INTO LUNGS. THE ACTUAL COMPLAINT PRODUCT WAS NOT RETURNED FOR EVALUATION; HOWEVER, TRACINGS RECORDED BY THE SUSPECTED DEVICE WERE PROVIDED AND ARE UNDER REVIEW. A REVIEW OF THE DEVICE HISTORY RECORD IS NOT POSSIBLE AS NO LOT NUMBER WAS PROVIDED. ALL INFORMATION REASONABLY KNOWN AS OF 23 AUG 2023 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 REPORTED EVENT BUT IS RELAYING THE INFORMATION PROVIDED BY THE USER FACILITY WHERE THE INCIDENT OCCURRED. THIS PRODUCT INCIDENT IS DOCUMENTED IN THE AVANOS MEDICAL 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.

    Additional Manufacturer Narrative · 0

    THE DEVICE HISTORY RECORD FOR SERIAL NUMBER (B)(6) AND (B)(6) WERE REVIEWED AND THE PRODUCTS WERE PRODUCED ACCORDING TO PRODUCT SPECIFICATIONS. THE CUSTOMER DID SEND IN A COPY OF THE TRACINGS OF THIS INCIDENT SO A CORVIEW CROSS-FUNCTIONAL REVIEW WAS COMPLETED. CORVIEW CROSS-FUNCTIONAL REVIEW NOTED THAT ALL TRACINGS PROVIDED DID NOT FOLLOW THE EXPECTED PATHWAY OF A TYPICAL GASTRIC PLACEMENT PATTERN WHEN REVIEWING THE MULTIPLE VIEWS TOGETHER. ADDITIONALLY, ALL TRACINGS EITHER INDICATED A DEVIATION INTO UPPER LEFT QUADRANT ON MONITOR UNIT SCREEN OR GREEN BALL HAD DIFFICULTY MOVING FORWARD. IMAGES OF THE OPTIMAL TRACING PATTERN (IN EACH VIEW) THAT SHOULD BE DISPLAYED ON THE MONITOR UNIT SCREEN ARE PROVIDED IN CORTRAK 2 EAS QUICK REFERENCE GUIDE, OPERATING AND TROUBLESHOOTING TIPS, AND OPERATOR¿S MANUAL. PER COMPLAINT DESCRIPTION, THE OPERATOR OF THE CORTRAK 2 EAS DURING THIS INCIDENT WAS A "NOVICE". CUSTOMER ALSO PROVIDED X-RAY REPORT AND STATED "XR TAKEN ON (B)(6) @ 0600, REPORT DOES NOT INDICATE CORTRAK TUBE WAS IN THE LUNG". HOWEVER, THE REPORT IMAGE PROVIDED STATES THE FOLLOWING UNDER FINDINGS "AN ENTERIC TUBE WITH APPEARS TO COIL WITHIN THE LEFT UPPER QUADRANT ABDOMEN WITH THE TIP PROJECTING OVER THE INFERIOR CHEST/LEFT UPPER QUADRANT ABDOMEN. GRADED OPACITY OF THE LEFT LUNG BASE, SUGGESTIVE OF A SMALL PLEURAL EFFUSION." THIS X-RAY REPORT INDICATES THERE WAS A POTENTIAL INJURY TO THE LUNG. THE ROOT CAUSE WAS RELATED TO USER: INCORRECT USE. ALL INFORMATION REASONABLY KNOWN AS OF 09 JAN 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 REPORTED EVENT BUT IS RELAYING THE INFORMATION PROVIDED BY THE USER FACILITY WHERE THE INCIDENT OCCURRED. THIS PRODUCT INCIDENT IS DOCUMENTED IN THE AVANOS MEDICAL 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

    ADDITIONAL INFORMATION RECEIVED ON 29AUG2023 REPORTED, INITIAL PLACEMENT OF THE NASOGASTRIC TUBE (NGT) OCCURRED ON (B)(6) 2023 AT 1038. LUNG PLACEMENT WAS DISCOVERED ON (B)(6) 2023 AROUND 1222. THE PATIENT WAS INTUBATED AT THE TIME OF NGT PLACEMENT. NO INITIAL X-RAY WAS TAKEN AFTER NGT PLACEMENT. X-RAY REPORT DID NOT INDICATE CORTRAK TUBE WAS IN THE LUNG. MEDICAL INTERVENTION INITIATED ON (B)(6) 2023 INCLUDED: STOP TRICKLE FEED, WHICH RAN FOR 30 MINUTES, AND HEPARIN DRIP. THE PATIENT DID NOT HAVE ANY UNUSUAL ANATOMY. THE CURRENT STATUS OF THE PATIENT WAS REPORTED TO BE DISCHARGED HOME.

    Description of Event or Problem · 0

    IT WAS REPORTED, A LUNG PLACEMENT OF A NASOGASTRIC (NG) TUBE OCCURRED VIA CORTRAK, RESULTING IN ENTERAL FEEDINGS BEING ADMINISTERED INTO THE PATIENT'S LUNG. CORRECT PLACEMENT OF NG TUBE WAS CONFIRMED VIA X-RAY BEFORE INITIATION OF FEEDS. A CHEST TUBE WAS PLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1525117 CORTRAK ENTERAL ACCESS SYSTEM DH CORTRAK (EAS) KNT AVANOS MEDICAL INC. 20-0950 20080011 00350770472010

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Male Other| R CORTRAK NASOGASTRIC TUBE| CORTRAK NASOGASTRIC TUBE 10 FR, 55 INCH| CORTRAK SRU: SN(B)(6)