MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2020-03-30 for CORTRAK 2 ENTERAL ACCESS SYSTEM 20-0950 104720102 manufactured by Avanos Medical Inc..
[186402483]
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.
Patient Sequence No: 1, Text Type: N, H10
[186402484]
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. "
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3011270181-2020-00052 |
| MDR Report Key | 9896810 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2020-03-30 |
| Date of Report | 2020-03-30 |
| Date of Event | 2020-02-13 |
| Date Mfgr Received | 2020-03-04 |
| Date Added to Maude | 2020-03-30 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | BIOMEDICAL ENGINEER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MS. LISA CLARK |
| Manufacturer Street | 5405 WINDWARD PARKWAY |
| Manufacturer City | ALPHARETTA GA 30004 |
| Manufacturer Country | US |
| Manufacturer Postal | 30004 |
| Manufacturer Phone | 4704485444 |
| Manufacturer G1 | CORPAK MEDSYSTEMS, INC. A DIVISION OF AVANOS |
| Manufacturer Street | 1001 ASBURY DR |
| Manufacturer City | BUFFALO GROVE IL 60089 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 60089 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CORTRAK 2 ENTERAL ACCESS SYSTEM |
| Generic Name | DH CORTRAK (EAS) |
| Product Code | KNT |
| Date Received | 2020-03-30 |
| Model Number | 20-0950 |
| Catalog Number | 104720102 |
| Lot Number | N/A |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | AVANOS MEDICAL INC. |
| Manufacturer Address | 5405 WINDWARD PARKWAY ALPHARETTA GA 30004 US 30004 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Death; 2. Life Threatening; 3. Other | 2020-03-30 |