THE SAMPLE IS REPORTED TO BE AVAILABLE, BUT HAS NOT YET BEEN RECEIVED BY THE MANUFACTURER. A REVIEW OF THE DEVICE HISTORY RECORD IS IN-PROGRESS. ALL INFORMATION REASONABLY KNOWN AS OF 28-MAR-2020 HAS BEEN INCLUDED IN THIS HEALTH AUTHORITY REPORT. SHOULD ADDITIONAL INFORMATION BE OBTAINED, A FOLLOW-UP HEALTH AUTHORITY REPORT WILL BE PROVIDED. 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.
D
Patient 1
IT WAS REPORTED THE CORTRAK DEVICE WAS USED FOR A NASOGASTRIC TUBE PLACEMENT ON (B)(6) 2020 AT 1130. THE PATIENT WAS ON A PULSE OXIMETER AND APPEARED STABLE. HE HAD A CONGESTED INTERMITTENT COUGH PRIOR TO THE PROCEDURE AND IT CONTINUED DURING THE PROCEDURE, WHICH WAS EXPECTED. THE PATIENT SWALLOWED AS HE WAS INSTRUCTED TO DO SO. THE PATIENT'S FULL COOPERATION WAS LIMITED BY CONFUSION. THE PATIENT'S OXYGEN SATURATIONS DROPPED TO 70% (ALSO EXPECTED) DURING THE PROCEDURE BUT RESOLVED WHEN THE CORTRAK TUBE WAS BRIDLED. AT 1230, THE RADIOLOGIST NOTED THE CORTRAK TUBE WAS MISPLACED IN THE LEFT PLEURAL SPACE VIA POTENTIAL LUNG PUNCTURE. THE PATIENT WAS STILL STABLE AND HIS PULSE OXIMETRY WAS CIRCA 90%. THE CORTRAK TUBE WAS REMOVED. THE PATIENT VERBALIZED AN IMPROVED ABILITY TO SPEAK. AT 1300 A FOLLOW-UP CHEST X-RAY SHOWED A PNEUMOTHORAX. AT 1800 THE PATIENT'S OXYGEN LEVEL DESATURATED TO 80% ON 5/LITERS OF OXYGEN VIA NASAL CANNULA. THE NURSE AND RESPIRATORY THERAPIST SWITCHED THE PATIENT TO 40% OXYGEN (8/LITERS) PER VENTI MASK. THE CHEST X-RAY WAS STABLE. ON (B)(6) 2020 AT 1314 THE CORTRAK IMPRESSION NOTED: MALPOSITIONED FEEDING TUBE EXTENDING INTO THE LEFT HEMITHORAX CONCERNING FOR LUNG PERFORATION WITH TUBE TIP IN THE POSTERIOR SULCUS PLEURAL SPACE. THE DEVICE WAS REMOVED AND NO SPECIFIC MEDICAL INTERVENTION WAS PERFORMED. ADDITIONAL INFORMATION RECEIVED 06-MAR-2020 STATED NO TREATMENT WAS REQUIRED. A CHEST X-RAY WAS PERFORMED AND NOTED A SMALL PNEUMOTHORAX THAT DID NOT REQUIRE A CHEST TUBE OR OTHER INTERVENTION. THE PATIENT DIED A FEW DAYS AFTER THIS INCIDENT FROM HIS PRIMARY DIAGNOSIS (NOT RELATED TO THE NASOGASTRIC TUBE INCIDENT). ADDITIONAL INFORMATION RECEIVED 13-MAR-2020 FROM THE USER STATED, "REGRETTABLY, WE WILL NOT BE RELEASING DETAILS SURROUNDING THE DEATH SINCE IT WAS NOT RELATED TO THE DEVICE IN QUESTION."