CORTRAK 2 ENTERAL ACCESS SYSTEM
Report
- Report Number
- 3011270181-2021-00057
- Event Type
- Injury
- Date Received
- December 13, 2021
- Date of Event
- November 9, 2021
- Report Date
- May 23, 2024
- Manufacturer
- AVANOS MEDICAL INC.
- Product Code
- KNT
- UDI-DI
- 00350770472010
- PMA / PMN Number
- K113351
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
THE SAMPLE IS REPORTED TO BE AVAILABLE BUT HAS NOT YET BEEN RECEIVED BY THE MANUFACTURER. A REVIEW OF THE DEVICE HISTORY RECORD IS NOT POSSIBLE AS NO LOT NUMBER WAS PROVIDED. ALL INFORMATION REASONABLY KNOWN AS OF 10-DEC-2021 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).
THE SAMPLE IS REPORTED TO BE AVAILABLE BUT HAS NOT YET BEEN RECEIVED BY THE MANUFACTURER. A REVIEW OF THE DEVICE HISTORY RECORD IS NOT POSSIBLE AS NO LOT NUMBER WAS PROVIDED. ALL INFORMATION REASONABLY KNOWN AS OF 10-DEC-2021 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).
THE DEVICE HISTORY RECORD FOR THE REPORTED LOT NUMBER, 20040541, IN THIS COMPLAINT WAS REVIEWED AND THE MATERIAL WAS PRODUCED ACCORDING TO THE MANUFACTURING PROCEDURES AND MET THE QUALITY REQUIREMENTS. THE SAMPLE DEVICE WAS EVALUATED. THE EVALUATION NOTED PLACEMENT TESTING WITH NO INCIDENTS AND THERE WERE NO TRACINGS OF INCIDENT PROVIDED; THE ROOT CAUSE OF THE INCIDENT WAS DETERMINED TO BE USE RELATED. ALL INFORMATION REASONABLY KNOWN AS OF 23-FEB-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, 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.
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, 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.
IT WAS REPORTED THE USER "INADVERTENTLY PLACED THE TUBE INTO THE LUNG AND PUNCTURED THE LUNG BUT IT WAS NOT CAPTURED ON THE CORTRAK AND MEDICATIONS WERE GIVEN." ADDITIONAL INFORMATION RECEIVED 03-DEC-2021 STATED THE EVENT WAS NOTED AS A RIGHT LUNG PLACEMENT CAUSING A PNEUMOTHORAX WITH PERFORATED BRONCHUS. THE EVENT OCCURRED ON (B)(6) 2021 AT 6:00PM. THE PATIENT WAS NOT INTUBATED DURING THE TIME OF THE EVENT BUT WAS ON OXYGEN THERAPY. INITIALLY, THE RADIOLOGIST CLEARED PLACEMENT WITH A KIDNEY, URETER, AND BLADDER (KUB) X-RAY. HOWEVER, THE FOLLOWING DAY A COMPUTED TOMOGRAPHY (CT) WAS PERFORMED, AND THE SCAN NOTED THE MAL-POSITIONED TUBE. TWO CHEST TUBES WERE PLACED DUE TO THE PNEUMOTHORAX. EVENTUALLY, THE PATIENT WAS DISCHARGED ON (B)(6) 2021.
IT WAS REPORTED THE USER "INADVERTENTLY PLACED THE TUBE INTO THE LUNG AND PUNCTURED THE LUNG BUT IT WAS NOT CAPTURED ON THE CORTRAK AND MEDICATIONS WERE GIVEN." ADDITIONAL INFORMATION RECEIVED 03-DEC-2021 STATED THE EVENT WAS NOTED AS A RIGHT LUNG PLACEMENT CAUSING A PNEUMOTHORAX WITH PERFORATED BRONCHUS. THE EVENT OCCURRED ON (B)(6) 2021 AT 6:00PM. THE PATIENT WAS NOT INTUBATED DURING THE TIME OF THE EVENT BUT WAS ON OXYGEN THERAPY. INITIALLY, THE RADIOLOGIST CLEARED PLACEMENT WITH A KIDNEY, URETER, AND BLADDER (KUB) X-RAY. HOWEVER, THE FOLLOWING DAY A COMPUTED TOMOGRAPHY (CT) WAS PERFORMED, AND THE SCAN NOTED THE MAL-POSITIONED TUBE. TWO CHEST TUBES WERE PLACED DUE TO THE PNEUMOTHORAX. EVENTUALLY, THE PATIENT WAS DISCHARGED ON (B)(6) 2021.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1880262 | CORTRAK 2 ENTERAL ACCESS SYSTEM | DH CORTRAK (EAS) | KNT | AVANOS MEDICAL INC. | 20-0950 | UNKNOWN | 00350770472010 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 48 YR | Male | Required Intervention | 20040532 |