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

Device Problems Leak/Splash (1354); Material Puncture/Hole (1504)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 03/02/2020

Event Type  malfunction  

Event Description

Nasogastric tube (ngt) placed, feed started.Patient 3/4 of way through feed and ngt found spraying formula out the side of tube out of a small hole.Ngt replaced.

• 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: 10074358
• MDR Text Key: 191570567
• Report Number: 10074358
• 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: 05/07/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/20/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• 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: 05/07/2020
• Event Location: Hospital
• Date Report to Manufacturer: 05/20/2020
• Type of Device Usage: N
• Patient Sequence Number: 1