MAUDE Adverse Event Report: AVANOS MEDICAL, INC. CORTRAK 2 ENTERNAL ACCESS DEVICE; TUBES, GASTROINTESTINAL (AND ACCESSORIES)

Model Number 46053

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/07/2024

Event Type  malfunction  

Event Description

Nurse was flushing medications through an avanos cortrak nasogastric feeding tube, when he heard a popping sound and the fluid he was flushing through tube exited the patient's mouth.After tube was removed it was found to have a significant hole in the tube.

• Brand Name: CORTRAK 2 ENTERNAL ACCESS DEVICE
• Type of Device: TUBES, GASTROINTESTINAL (AND ACCESSORIES)
• Manufacturer (Section D): AVANOS MEDICAL, INC.; 5405 windward parkway; alpharetta GA 30004
• MDR Report Key: 19010645
• MDR Text Key: 339006767
• Report Number: 19010645
• Device Sequence Number: 1
• Product Code: KNT
• UDI-Device Identifier: 00350770460536
• UDI-Public: (01)00350770460536
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 03/08/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/01/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: 46053
• Device Catalogue Number: 40-9551TRAK2
• Device Lot Number: 30252001
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 03/08/2024
• Event Location: Hospital
• Date Report to Manufacturer: 04/01/2024
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 28 DA
• Patient Sex: Male
• Patient Weight: 67 KG