MAUDE Adverse Event Report: AVANOS MEDICAL, INC. AVANOS CORFLO NASOGASTRIC/NASOINTESTINAL FEEDING TUBE WITH ENFIT CONNECTOR; TUBES, GASTROINTESTINAL (AND ACCESSORIES)

Model Number 40-1366

Device Problems Crack (1135); Material Twisted/Bent (2981)

Patient Problem Vomiting (2144)

Event Date 01/23/2022

Event Type  malfunction  

Event Description

Patient had a 6 french nasogastric tube that had been repositioned/used most recently in an upper gi study to evaluate feeding intolerance.Prior to the study the tube was post-pyloric.Tube was pulled back into stomach for gi study.Following the study, the tube was advanced post-pyloric again for feeding as patient was not tolerating gastric feeds due to frequent emesis.Xray verification at all steps.Patient had emesis overnight that looked like tube feedings despite post pyloric placement.Xray showed tube coiled in stomach with tip still post pyloric.Decision made to pull back feeding tube to keep tip post pyloric but alleviate coiling.Upon pulling back tube, feeding tube is cracked and almost separated into two pieces.Patient was likely being fed gastric for several days resulting in excessive emesis.

• Brand Name: AVANOS CORFLO NASOGASTRIC/NASOINTESTINAL FEEDING TUBE WITH ENFIT CONNECTOR
• Type of Device: TUBES, GASTROINTESTINAL (AND ACCESSORIES)
• Manufacturer (Section D): AVANOS MEDICAL, INC.; 5405 windward parkway; alpharetta GA 30004
• MDR Report Key: 13505386
• MDR Text Key: 285398868
• Report Number: 13505386
• Device Sequence Number: 1
• Product Code: KNT
• UDI-Device Identifier: 00350770459981
• UDI-Public: 00350770459981
• 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: 02/02/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/10/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: 40-1366
• Device Catalogue Number: 40-1366
• Device Lot Number: 30161252
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 02/02/2022
• Event Location: Hospital
• Date Report to Manufacturer: 02/10/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1