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

Model Number 40-9431

Patient Problem Insufficient Information (4580)

Event Date 01/26/2024

Event Type  malfunction  

Event Description

The hospital recently began using avanos nasogastric feeding tube with enfit connector.This brand of dobhoff tube is a newer product for us.The design of this product includes two lumens, therefore allowing tube feeds to be administered with the guidewire in place.The previous nasogastric tube used by the hospital had a single lumen, and therefore it was not possible to administer tube feeds with the guidewire in place.The hospital has had some adverse and near-miss events involving where tube feeds were administered or nearly administered with the guidewire still in place.We have communicated with the manufacturer regarding this issue.We suggested the product include a visual cue on the outside of the tubing to indicate that the guidewire is in place.We also recommended that the manufacturer add a visual cue on the proximal end of the guidewire to state ¿remove before feeding.¿ manufacturer response for nasogastric feeding tube/ dobhoff, avanos (per site reporter), i am not aware of a response.

• Brand Name: AVANOS
• Type of Device: TUBES, GASTROINTESTINAL (AND ACCESSORIES)
• Manufacturer (Section D): AVANOS MEDICAL, INC.; 5405 windward parkway; alpharetta GA 30004
• MDR Report Key: 18836323
• MDR Text Key: 336884739
• Report Number: 18836323
• 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: 02/06/2024,02/14/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/05/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: 40-9431
• Device Catalogue Number: 40-9431, 40-9551
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 02/06/2024
• Event Location: Hospital
• Date Report to Manufacturer: 03/05/2024
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 68 YR
• Patient Sex: Male