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

Model Number 46053

Device Problems Difficult to Remove (1528); Device Displays Incorrect Message (2591)

Patient Problem Insufficient Information (4580)

Event Date 11/27/2020

Event Type  malfunction  

Event Description

First, no ett (endotracheal tube).Patient was on a nasal cannula.Ng, cortrak feeding tube was placed using cortrak 2.When ready to hit "start" (ng in back of mouth), the machine kept erroring.Since procedure was already started, ng was advanced and x-ray obtained with tube in good position.At this point, guidewire was unable to be removed.There were no kinks or loops on x-ray.Tube was removed and a new one placed.

• Brand Name: CORTRAK 2 FEEDING TUBE
• Type of Device: TUBES, GASTROINTESTINAL (AND ACCESSORIES)
• Manufacturer (Section D): AVANOS MEDICAL, INC.; 5405 windward parkway; alpharetta GA 30004
• MDR Report Key: 11002225
• MDR Text Key: 221255494
• Report Number: 11002225
• Device Sequence Number: 1
• Product Code: KNT
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 12/10/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/14/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 46053
• Device Catalogue Number: 40-9551TRAK2
• Device Lot Number: 30084775
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 12/10/2020
• Event Location: Hospital
• Date Report to Manufacturer: 12/14/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1