BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CORTRAK ENTERAL ACCESS SYSTEM

    MDR report key: 17669396 · Received September 1, 2023

    Report

    Report Number
    3011270181-2023-00118
    Event Type
    Injury
    Date Received
    September 1, 2023
    Date of Event
    July 14, 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
    US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PER WARNINGS IN CORTRAK 2 NASOGASTRIC/NASOINTESTINAL FEEDING TUBE WITH ELECTROMAGNETIC TRANSMITTING STYLET INSTRUCTIONS FOR USE, ADDITIONAL CONFIRMATORY TECHNIQUES MAY BE INDICATED FOR PATIENTS WHO ARE COMBATIVE OR MOVE EXCESSIVELY DURING PLACEMENT. THEREFORE, SINCE THE USER CONFIRMED THAT THE RECEIVER UNIT WAS NOT IN THE CORRECT ANATOMICAL LOCATION, THE PATIENT WAS COMBATIVE, AND PER WARNINGS IN CORTRAK 2 NG/NI FEEDING TUBE IFU; THE ROOT CAUSE WAS DETERMINED TO BE USER-INCORRECT USE. ALL INFORMATION REASONABLY KNOWN AS OF 04 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

    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. A ROOT CAUSE COULD NOT BE DETERMINED. ALL INFORMATION REASONABLY KNOWN AS OF 31 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.

    Additional Manufacturer Narrative · 0

    CORRECTION: H6 INVESTIGATION FINDINGS; ADDED DEVICE PROBLEM CODE; H10 H6: INVESTIGATION FINDINGS/NO CODE AVAILABLE: USAGE PROBLEM IDENTIFIED. PER THE COMPLAINT DESCRIPTION, ¿X-RAY WAS TAKEN MID-PROCEDURE, AND THE TUBE WAS COILED; ON FOLLOW-UP X-RAY, THERE WAS A PNEUMO [PNEUMOTHORAX] NOTED.¿ THERE ARE WARNINGS IN THE CORTRAK2 IFUS THAT INSTITUTION PROTOCOLS MUST ALWAYS SUPERSEDE THE USE OF THE CORTRAK 2. CLINICAL JUDGMENT MUST ALWAYS TAKE PRECEDENCE¿, ¿FEEDING TUBE SHOULD BE WITHDRAWN IMMEDIATELY IF SYMPTOMS OF RESPIRATORY DISTRESS OR IRRITATION¿, AND ¿WITHDRAW THE TUBE IMMEDIATELY IF ANY RESISTANCE IS ENCOUNTERED DURING THE PLACEMENT¿. THEREFORE, SINCE AN X-RAY WAS TAKEN MID-PROCEDURE (INDICATING USERS WERE AWARE OF THE POTENTIAL ISSUES), THE WARNINGS IN THE CORTRAK 2 IFUS WERE NOT ADHERED TO. THEREFORE, THE ROOT CAUSE WAS DETERMINED TO BE 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

    IT WAS REPORTED, A PNEUMOTHORAX OCCURRED WITH THE USE OF CORTRAK WHICH REQUIRED AN EMERGENT CHEST TUBE PLACEMENT. THE PATIENT WAS COMBATIVE DURING PLACEMENT AND THE RECEIVER UNIT WAS NOT MAINTAINED IN PLACED. AN XRAY WAS TAKEN MID-PROCEDURE AND THE TUBE WAS COILED. ON FOLLOW-UP XRAY, THERE WAS A PNEUMOTHORAX NOTED. THE PATIENT STABILIZED AND WAS TRANSFERRED OUT OF THE INTENSIVE CARE UNIT (ICU). NO DEVICE MALFUNCTION OR PROBLEM REPORTED. PER ADDITIONAL INFORMATION RECEIVED ON 17 AUG 2023, THE CORTRAK UNIT IS OPERATING FINE AND WILL NOT BE SENT IN FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1390460 CORTRAK ENTERAL ACCESS SYSTEM DH CORTRAK (EAS) KNT AVANOS MEDICAL INC. 20-0950 UNKNOWN 00350770472010

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Life Threatening| R| O CORTRAK NASOGASTRIC TUBE| CORTRAK SMART RECEIVER UNIT