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

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

Event Date 01/08/2024

Event Type  malfunction  

Event Description

Registered nurse caring for the patient was administering medication through the feeding tube when a popping sound was heard.Subsequently the rn removed the feeding tube and discovered it had fractured, with imaging revealing that a portion remained in the stomach.Later in the day, the tube was visualized in the oral pharynx and physician successfully removed it.Fortunately, there was no harm to the patient.

• Type of Device: TUBES, GASTROINTESTINAL (AND ACCESSORIES)
• Manufacturer (Section D): AVANOS MEDICAL, INC.; 5405 windward parkway; alpharetta GA 30004
• MDR Report Key: 19104551
• MDR Text Key: 340141777
• Report Number: 19104551
• 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: Risk Manager
• Type of Report: Initial
• Report Date: 01/17/2024

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
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/17/2024
• Date Report to Manufacturer: 04/15/2024
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/15/2024
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 56 YR