MAUDE Adverse Event Report: AVANOS MEDICAL INC. CORTRAK 2 ENTERAL ACCESS SYSTEM; DH CORTRAK (EAS)

Model Number 20-0950

Device Problem Malposition of Device (2616)

Patient Problem Pneumothorax (2012)

Event Date 03/28/2022

Event Type  Death  

Event Description

It was reported that the patient was discovered to have a pneumothorax the day after the nasogastric tube (ng) tube was placed, an x-ray confirmed the placement in the right lung; the patient reportedly had chest tubes placed and was in the intensive care unit.It was additionally reported that the nurse, that placed the cortrak device, stated that the cortrak unit was not acting normal but they were not sure what the issue was.Additional information received on 08apr2022 reported, the cortrak tube placement was a replacement feeding tube after the ng tube was dislodged, after extubation.The right lung pneumothorax was confirmed via chest x-ray and kidney, ureter and bladder (kub) xray; a 14f wayne chest catheter was placed.The patient reportedly expired; the death was noted as not related to the feeding tube incident.

Manufacturer Narrative

The actual complaint product was not returned for evaluation.The device history record for lot 1604014 was reviewed and the product was produced according to product specifications.All information reasonably known as of 03 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.

Manufacturer Narrative

The cortrak 2 eas was returned to minnetronix for sample evaluation, mu 1604014 and ru 1710014 both passed placement test.Ru did not exhibit self-test failure, the unit functioned as intended.Examination of the tracings obtained from the sample cortrak system were evaluated by the avanos corview cross-functional team and it was discovered that there were multiple indications on multiple tracings that the feeding tube tracing started in the incorrect position, encountered resistance and entered the lung.The root cause is determined to be: the customer did not follow warnings in approved and released ifu for cortrak feeding tube; the root cause for this incident was determined to be user/incorrect use.All information reasonably known as of 08 jun 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 21 cfr 803, 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.

Manufacturer Narrative

All information reasonably known as of 20-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.

• Brand Name: CORTRAK 2 ENTERAL ACCESS SYSTEM
• Type of Device: DH CORTRAK (EAS)
• Manufacturer (Section D): AVANOS MEDICAL INC.; 5405 windward parkway; alpharetta GA 30004
• Manufacturer (Section G): MINNETRONIX, INC.; 1635 energy park dr.; saint paul MN 55108
• Manufacturer Contact: lisa clark ; 5405 windward parkway; alpharetta, GA 30004 ; 4704485444
• MDR Report Key: 14283057
• MDR Text Key: 290708412
• Report Number: 3011270181-2022-00027
• Device Sequence Number: 1
• Product Code: KNT
• UDI-Device Identifier: 00350770472010
• UDI-Public: 00350770472010
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K113351
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 06/09/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/04/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2023
• Device Model Number: 20-0950
• Device Catalogue Number: N/A
• Device Lot Number: 1604014
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/17/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/10/2018
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Treatment: SRU UNIT 1710014; WAYNE CHEST CATHETER
• Patient Outcome(s): Life Threatening; Death; Required Intervention
• Patient Age: 37 YR
• Patient Sex: Female
• Patient Weight: 51 KG