MAUDE Adverse Event Report: ENFIT ENTERAL FEEDING CONNECTION; ENFIT FEEDING TUBE

Device Problem Connection Problem (2900)

Patient Problem Stomach Ulceration (4488)

Event Date 12/28/2020

Event Type  malfunction  

Event Description

The event- involves the enfit enteral feeding connection and enfit feeding tube.It is designed to reduce the number of missed connections.However, the connection does not pull away from the peg tube if tension is detected thus causing the peg to pull against the abdominal wall.This can cause dislodgement and harm to the patient.The patient then requires additional intervention/procedures to correct any potential or actual harm.This patient's peg was lodged in the anterior abdominal wall and pulling stomach up into it.There was also a large ulceration noted in the stomach caused by the peg.Fda safety report id# (b)(4).

• Brand Name: ENFIT ENTERAL FEEDING CONNECTION
• Type of Device: ENFIT FEEDING TUBE
• MDR Report Key: 11444793
• MDR Text Key: 239108787
• Report Number: MW5099863
• Device Sequence Number: 1
• Product Code: FPD
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 03/05/2021
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 03/08/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 48 YR