CORTRAK 2 ENTERAL ACCESS SYSTEM
Report
- Report Number
- 3011270181-2022-00025
- Event Type
- Death
- Date Received
- April 20, 2022
- Date of Event
- March 9, 2022
- Report Date
- May 23, 2024
- Manufacturer
- AVANOS MEDICAL INC.
- Product Code
- KNT
- UDI-DI
- 00350770472010
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OH, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
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. ROOT CAUSE COULD NOT BE DETERMINED. ALL INFORMATION REASONABLY KNOWN AS OF ON (B)(6) 2022 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 COMPLAINT DATABASE AND IDENTIFIED AS COMPLAINT (B)(4).
THE DEVICE HISTORY RECORD FOR THE REPORTED LOT NUMBER IN THIS COMPLAINT WAS REVIEWED AND THE MATERIAL WAS PRODUCED ACCORDING TO THE MANUFACTURING PROCEDURES AND MET THE QUALITY REQUIREMENTS. THE ACTUAL SAMPLE FROM THE REPORTED EVENT WAS EVALUATED. TESTING OF THE SAMPLE REVEALED THAT THE RU DID NOT EXHIBIT SELF-TEST FAILURE, NOR COULD THE PLACEMENT FAILURE BE REPEATED. THE PATIENT FILES WERE UPLOADED, REVIEW OF TRACING (B)(4) SHOWED ON THE MU SCREEN THAT THE NASOGASTRIC (NG) TUBE TIP ENTERED THE RIGHT LUNG AREA AT 2 SECONDS INTO THE TRACING AND THE TUBE TIP PATHWAY CONTINUED FORWARD INTO THE RIGHT LUNG AREA DURING THE REST OF TRACING. THE AVANOS MEDICAL, INC REVIEWED TRACING (B)(4) AND NOTED IT DOES NOT FOLLOW TYPICAL PLACEMENT PATTERN INDICATED IN CORTRAK2 ENTERAL ACCESS SYSTEM ELECTROMAGNETIC TRANSMITTING STYLET AND CORFLO FEEDING TUBE INSTRUCTIONS FOR USE (IFU). THE TRACING (B)(4) SHOWED THE TUBE TIP PATHWAY HAD GONE INTO THE RIGHT LUNG AREA ON MU SCREEN, THE ROOT CAUSE WAS IDENTIFIED AS ¿USER: INCORRECT USE¿. ALL INFORMATION REASONABLY KNOWN AS OF 22 AUG 2022 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 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.
THE SAMPLE IS REPORTED TO BE AVAILABLE, BUT HAS NOT YET BEEN RECEIVED BY THE MANUFACTURER. THE DEVICE HISTORY RECORD FOR LOT 1803023 WAS REVIEWED AND THE PRODUCT WAS PRODUCED ACCORDING TO PRODUCT SPECIFICATIONS. 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. ROOT CAUSE COULD NOT BE DETERMINED. ALL INFORMATION REASONABLY KNOWN AS OF 16 MAY 2022 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 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.
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 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.
A PNEUMOTHORAX EVENT WAS REPORTED; THE PATIENT¿S CONDITION WAS NOT PROVIDED. ADDITIONAL INFORMATION RECEIVED 24-MAR-2022 REPORTED, PATIENT WAS FOUND 'DOWN', FOLLOWING A WELLNESS CHECK. A DIGESTIVE HEALTH TUBE (DHT) WAS PLACED IN THE LEFT NARE FOR MEDICATION ADMINISTRATION USING THE CORTRAK MACHINE, [THE DISPLAY] INDICATED THE TUBE WAS POSITIONED CORRECTLY. A CHEST AND ABDOMINAL (ABD) X-RAY WERE OBTAINED AND THE CHEST X-RAY REVEALED THE TUBE WAS IN THE RIGHT-LUNG; THE PATIENT WAS SYMPTOMATIC AND THE TUBE WAS PULLED. A SUBSEQUENT CHEST X-RAY REVEALED A SMALL RIGHT-PNEUMOTHORAX.
ADDITIONAL INFORMATION RECEIVED 18APR2022 REPORTED THAT THE PATIENT WAS NOT INTUBATED AT THE TIME OF THE EVENT AND NO MEDICAL INTERVENTION WAS PROVIDED AT THE TIME; THE PATIENT WAS REPORTEDLY STABLE AT THE TIME OF THE REPORT. ADDITIONAL INFORMATION RECEIVED 25-APR-2022 FROM FDA MEDWATCH/ FDA USER FACILITY REPORT # MW5109026 REPORTED THE PATIENT HAD THE DIGESTIVE HEALTH FEEDING TUBE PLACED FOR ADMINISTRATION OF THE CHEMO AGENT. THE REGISTERED NURSE NOTIFIED THE PROVIDER THAT THE PATIENT WAS HAVING INCREASED SECRETIONS AND OXYGEN REQUIREMENTS DUE TO DESATURATION. THE PATIENT REFUSED THE OFFERED CHEST TUBE AND MADE HIMSELF: DO NOT RESUSCITATE (DNR) AND DO NOT INTUBATE (DNI). THE PATIENT REPORTEDLY DIED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1266739 | CORTRAK 2 ENTERAL ACCESS SYSTEM | DH CORTRAK (EAS) | KNT | AVANOS MEDICAL INC. | 20-0950 | 1803023 | 00350770472010 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 89 YR | Male | Required Intervention| D| O| L | (B)(6). |