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

Model Number 20-9551TRAK2

Device Problems Incorrect, Inadequate or Imprecise Result or Readings (1535); Device Displays Incorrect Message (2591)

Patient Problem Insufficient Information (4580)

Event Date 10/06/2020

Event Type  malfunction  

Event Description

Style error message, unable to use the feeding tube.We've had this issue before - the tubes don't read correctly via the cortrak monitor.One thing the rd's have also noticed is that the expiration on them tends to be sooner rather than later as we thought we'd removed the faulty lot #'s and then they seem to reappear or it's a new faulty lot.I don't think there's any patient safety issues with it.The cortrak is on its last leg too but these seem to be the tubes.We will be continuing to use this machine for pediatric ft placements.Avanos manufacturer has been notified.

• Brand Name: CORTRAK 2 EAS ELECTROMAGNETIC TRANSMITTING STYLET AND CORFLO FEEDING TUBE
• Type of Device: TUBES, GASTROINTESTINAL (AND ACCESSORIES)
• Manufacturer (Section D): AVANOS MEDICAL, INC.; 5405 windward parkway; alpharetta GA 30004
• MDR Report Key: 10669675
• MDR Text Key: 211017366
• Report Number: 10669675
• 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: 10/08/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/13/2020
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 20-9551TRAK2
• Device Catalogue Number: 20-9551TRAK2
• Device Lot Number: 30084759
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 10/08/2020
• Event Location: Hospital
• Date Report to Manufacturer: 10/13/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 19345 DA
• Patient Weight: 59