MAUDE Adverse Event Report: AVANOS MEDICAL, INC. CORFLO; TUBES, GASTROINTESTINAL (AND ACCESSORIES)

Model Number 40-9368

Device Problems Difficult to Flush (1251); Leak/Splash (1354)

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

Event Date 06/15/2023

Event Type  malfunction  

Event Description

Corflo feeding tube was placed for nasogastric feeding.Following feed, the tube was flushed with water and noted to be leaking around the connector site where the yellow tube meets the bifurcation of the distal connections.

• Brand Name: CORFLO
• Type of Device: TUBES, GASTROINTESTINAL (AND ACCESSORIES)
• Manufacturer (Section D): AVANOS MEDICAL, INC.; 5405 windward parkway; alpharetta GA 30004
• MDR Report Key: 17224478
• MDR Text Key: 318099126
• Report Number: 17224478
• 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: 06/21/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/29/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: 40-9368
• Device Lot Number: 30242096
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 06/21/2023
• Device Age: 0 YR
• Event Location: Hospital
• Date Report to Manufacturer: 06/29/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 1460 DA
• Patient Sex: Male