MAUDE Adverse Event Report: AVANOS MEDICAL INC. CORTRAK 2 NASOGASTRIC/NASOINTESTINAL FEEDING TUBE WITH ELECTROMAGNETIC TRANSMIT; DH CORTRAK DISPOSABLES

Model Number	20-9432TRAK2
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Death (1802); Perforation (2001); Rupture (2208)
Date of Event	02/18/2020
Type of Reportable Event	Death
Additional Manufacturer Narrative
The actual complaint product was not returned for evaluation.A review of the device history record is not possible as no lot number was provided.Root cause could not be determined.All information reasonably known as of 16 mar 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).
Event or Problem Description
It was reported that "during insertion the patient's nare ruptured and they had a massive bleed.Patient died.This was due to a massive clot bleed." additional information has been requested but not yet received.

• Brand Name: CORTRAK 2 NASOGASTRIC/NASOINTESTINAL FEEDING TUBE WITH ELECTROMAGNETIC TRANSMIT
• Common Device Name: DH CORTRAK DISPOSABLES
• Manufacturer (Section D): AVANOS MEDICAL INC.; 5405 windward parkway; alpharetta GA 30004
• MDR Report Key: 9838104
• Report Number: 9611594-2020-00045
• Device Sequence Number: 13840760
• Product Code: KNT
• UDI-Device Identifier: 10680651458022
• UDI-Public: 10680651458022
• Combination Product (Y/N): N
• Initial Reporter State: DE
• Initial Reporter Country: US
• PMA/510(K) Number: K821906
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 03/16/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 20-9432TRAK2
• Device Catalogue Number: 104580201
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/19/2020
• Initial Report FDA Received Date: 03/16/2020
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Death