MAUDE Adverse Event Report: AVANOS MEDICAL, INC. CORTRAK 2 EAS ELECTROMAGNETIC TRANSMITTING STYLET AND CORFLO FEEDING TUBE; TUBES, GASTROINTESTINAL (AND ACCESSORIES)

Model Number	40-9368TRAK2
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	06/23/2019
Type of Reportable Event	Malfunction
Event or Problem Description
A nasogastric tube was inserted under direct fluoroscopy.The nasogastric tube remained intact until approximately five days later when x-rays showed that the tip had broken off and was noted to be in the colon.

• Brand Name: CORTRAK 2 EAS ELECTROMAGNETIC TRANSMITTING STYLET AND CORFLO FEEDING TUBE
• Common Device Name: TUBES, GASTROINTESTINAL (AND ACCESSORIES)
• Manufacturer (Section D): AVANOS MEDICAL, INC.; 5405 windward parkway; alpharetta GA 30004
• MDR Report Key: 8935408
• Report Number: 8935408
• Device Sequence Number: 1938382
• Product Code: KNT
• UDI-Device Identifier: 10815149020874
• UDI-Public: (01)10815149020874
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 07/17/2019
• Report Date (Section F): 07/17/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: No Information
• Device Model Number: 40-9368TRAK2
• Device Catalogue Number: 40-9368TRAK2
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 08/27/2019
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/27/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Date Report Sent to FDA: 07/17/2019