BEUDAMED
    FDA Adverse Event Death Summary report: N

    CORTRAK 2 NG/NI FEEDING TUBE, ELECTROMAGNETIC STYLET

    MDR report key: 16897266 · Received May 9, 2023

    Report

    Report Number
    9611594-2023-00061
    Event Type
    Death
    Date Received
    May 9, 2023
    Date of Event
    March 15, 2023
    Report Date
    June 27, 2023
    Manufacturer
    AVANOS MEDICAL INC.
    Product Code
    KNT
    UDI-DI
    00350770460536
    PMA / PMN Number
    K821906
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H6 HEALTH EFFECT - CLINICAL CODE: LUNG PLACEMENT H6 HEALTH EFFECT - IMPACT CODE: DEATH 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. ALL INFORMATION REASONABLY KNOWN AS OF (B)(6) 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 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. H3 OTHER TEXT : THE DEVICE WAS NOT RETURNED.

    Additional Manufacturer Narrative · 0

    THE INVESTIGATION CONCLUSION NOTED PER WARNINGS IN THE INSTRUCTIONS FOR USE (IFU), ADDITIONAL CONFIRMATORY TECHNIQUES MAY BE INDICATED FOR PATIENTS WHO ARE COMBATIVE OR MOVE EXCESSIVELY DURING PLACEMENT. THEREFORE, BASED ON THE FACT THAT FEEDING TUBE WAS PLACED WITHOUT USE OF CORTRAK 2 ENTERAL ACCESS SYSTEM, CUSTOMER PERFORMED SEVERAL CONFIRMATORY METHODS PER THEIR INSTITUTION PROTOCOL AND SAID DEVICE WAS OKAY TO USE, AND PATIENT WAS EXTREMELY COMBATIVE DURING PLACEMENT. THE ROOT CAUSE OF THIS ISSUE WAS DETERMINED TO BE "USER: INCORRECT USE". ALL INFORMATION REASONABLY KNOWN AS OF 26-JUN-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 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 · 0

    IT WAS REPORTED VIA FDA MEDWATCH / FDA USER FACILITY REPORT 2400010000-2023-8008 THE FOLLOWING INFORMATION: DESCRIBE THE EVENT OR PROBLEM: CUSTOMER ADMITTED TO A DIFFERENT HOSPITAL DUE TO SHORTNESS OF BREATH, RESPIRATORY FAILURE AND BECAUSE CUSTOMER'S MANY COMPLICATED HEALTH ISSUES, HE WAS TRANSFERRED TO THIS HOSPITAL FOR ONGOING CARE. DAUGHTER OF THIS CUSTOMER REQUESTED DNR/DNI [DO NOT RESUSCITATE ORDER (DNR)/DO NOT INTUBATE ORDER (DNI)]. CUSTOMER HAD SEVERE OROPHARYNGEAL DYSPHAGIA AND WAS NOT ABLE TO TAKE IN ORAL NUTRIENTS. EVEN THOUGH THIS CUSTOMER WAS DNR/DNI, THE FAMILY WANTED RESTORATIVE TREATMENT VIA NASOGASTRIC (NG) TUBE FEEDING TO SEE IF THE CUSTOMER COULD GET STRONG ENOUGH TO COME HOME. FOR THE ENTIRE STAY, CUSTOMER WAS AGITATED AND WOULD PULL OUT IVS AND PULL AT OTHER TUBES AND FOLEY CATHETER. ONCE DAUGHTER CONSENTED TO THE NG TUBE, THE CARE TEAM TRIED TO MANUALLY INSERT THE NG WITH A NASAL BRIDLE AND THE CUSTOMER WAS AGITATED AND VERY COMBATIVE. IN ORDER TO COMPLETE THIS PROCEDURE, 6 TEAM MEMBERS WERE NEEDED TO RESTRAIN THE CUSTOMER. RESTRAINTS WERE ORDERED DUE TO THE PULLING AT TUBES AND NOT FOLLOWING COMMANDS. AFTER PLACEMENT, NURSES AUSCULTATE AIR IN ABDOMEN AND CUSTOMER ASPIRATES GI [GASTROINTESTINAL] CONTENTS BACK. X-RAY NG PLACEMENT VERIFICATION X1: IMPRESSION: CUSTOMER IS OBLIQUED DURING THE EXAMINATION. SUSPECT COILED FEEDING TUBE IN A HIATAL HERNIA TERMINATING IN THE MID TO DISTAL STOMACH HOWEVER REPEAT EXAMINATION WILL BE PERFORMED TO CONFIRM LOCATION. BEDSIDE RN CALLS RADIOLOGIST TO CONFIRM "OKAY TO USE," REPEAT X-RAY TO BE DONE PER RADIOLOGIST MD. X-RAY NG PLACEMENT VERIFICATION X2: IMPRESSION: FEEDING TUBE APPEARS TO BE LOOPED WITHIN A HIATAL HERNIA AND EXTENDS INFERIORLY AT THE GE [ GASTROESOPHAGEAL] JUNCTION TERMINATING IN THE LEFT MID ABDOMEN LIKELY WITHIN THE MID TO DISTAL STOMACH. IMAGES WERE TAKEN FOR PLACEMENT VERIFICATION AND BEDSIDE RN CALLED RADIOLOGIST TO CONFIRM "OKAY TO USE" NG. ONCE TUBE FEEDING WAS INITIATED, CUSTOMER WAS PLACED ON BIPAP [BILEVEL POSITIVE AIRWAY PRESSURE] FOR INCREASED AGITATION. CUSTOMER'S CONDITION DECLINED AND RAPID RESPONSE CALLED, STAT X-RAY ORDERED, AND TUBE FEEDING STOPPED. A BRONCHOSCOPY WAS COMPLETED, AND IT WAS NOTED THAT THE NG TUBE WAS PLACED IN THE LUNG AND TUBE FEEDING WAS GOING TO THE LUNG (RECEIVED TUBE FEEDINGS FOR SEVERAL HOURS). NG REMOVED AND THE NEXT DAY, THE FAMILY DECIDED ON COMFORT CARES AND THE CUSTOMER EXPIRED POST BIPAP REMOVAL. PATIENT PASSED AWAY. ADDITIONAL INFORMATION RECEIVED (B)(6) 2023: "WHILE A CORTRAK CAPABLE FEEDING TUBE WAS USED, THE FEEDING TUBE PLACEMENT WAS DONE VIA A BLIND INSERTION. THE CORTRAK2 MACHINE WAS NOT USED. A BRONCHOSCOPY WAS DONE AND THE FEEDING TUBE WENT TO THE PATIENT¿S LEFT LUNG, LOWER LOBE. THE PATIENT WAS TRANSITIONED TO OXYMASK WITH NG PLACEMENT AND 5-HOURS LATER WAS PLACED ON BIPAP FOR INCREASED WOB [BILEVEL POSITIVE AIRWAY PRESSURE]/RR[RESPIRATION RATE]/AGITATION."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1901918 CORTRAK 2 NG/NI FEEDING TUBE, ELECTROMAGNETIC STYLET DH CORTRAK DISPOSABLES KNT AVANOS MEDICAL INC. 40-9551TRAK2 UNKNOWN 00350770460536

    Patients

    Seq Age Sex Outcome Treatment
    1 85 YR Male Death