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 Problems Death (1802); Pleural Effusion (2010)

Event Date 08/30/2019

Event Type  Death  

Manufacturer Narrative

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 27-sep-2019 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.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 was not returned.

Event Description

It was reported a lung placement occurred.Additional information received (b)(6) 2019 stated the device was placed on (b)(6) 2019 between 11:33am and 12:38am." the device was placed in the left lung.Additional information received (b)(6) 2019 stated the user facility records show the feeding tube was placed at noon on (b)(6) 2019.The placement was confirmed by radiology that same day and again by another x-ray on (b)(6) 2019.On (b)(6) 2012 a chest ct scan showed the tube was in the left lung.The feeding tube was removed post chest ct.The patient had a chest tube placed on (b)(6) 2019 which was unrelated to the feeding tube being in the lung.The patient's nurse realized something was wrong when she noticed enteral nutrition coming out of the chest tube which is why the chest ct was done on (b)(6) 2019.The patient was terminally ill and passed away on (b)(6) 2019.

Manufacturer Narrative

The device history record for the reported serial number in this complaint was reviewed and the material was produced according to the manufacturing procedures and met the quality requirements.All information reasonably known as of 27-dec-2019 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.

Event Description

Additional information received 04-dec-2019 stating the patient's.Cause of death was listed as multi-organ failure as related to history of multiple myeloma.

Manufacturer Narrative

The device history record for the reported lot number, 1203008, in this complaint was reviewed and the material was produced according to the manufacturing procedures and met the quality requirements.All information reasonably known as of (b)(6) 2020 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.

Manufacturer Narrative

The follow-up number two for report number 3006646024-2019-00019 was submitted as a follow-up number two report for 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.All information reasonably known as of 14-jan-2020 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.

• 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
• MDR Report Key: 9131581
• MDR Text Key: 160440653
• Report Number: 3006646024-2019-00019
• Device Sequence Number: 1
• Product Code: KNT
• UDI-Device Identifier: 00350770472010
• UDI-Public: 00350770472010
• Combination Product (y/n): N
• PMA/PMN Number: K113351
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 01/15/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/27/2019
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 20-0950
• Device Catalogue Number: 104720102
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/18/2019
• Patient Sequence Number: 1
• Patient Outcome(s): Death
• Patient Age: 59 YR
• Patient Weight: 78