MAUDE Adverse Event Report: ZEVEX , INC. INFINITY 500 ML FEEDING BAG SET WITH ENFIT CONNECTOR; GASTROINTESTINAL TUBES WITH ENTERAL SPECIFIC CONNECTORS

Model Number	INF0500-E
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	04/13/2023
Type of Reportable Event	Malfunction
Event or Problem Description
The nurse connected the enteralite feeding bag to patient and noted there was leaking around the connections site.She tried to connect to both an nj and a g-tube with leaking at both.2 additional bags from the storage room were tried and they also leaked.It was noted that all three bags came from the same lot number.The nurse went to another floor and obtained a bag from a different lot number and was able to successfully provide feedings to the patient without leakage.

• Brand Name: INFINITY 500 ML FEEDING BAG SET WITH ENFIT CONNECTOR
• Common Device Name: GASTROINTESTINAL TUBES WITH ENTERAL SPECIFIC CONNECTORS
• Manufacturer (Section D): ZEVEX , INC.; 4314 zevex park lane; salt lake city UT 84123
• MDR Report Key: 16775558
• Report Number: 16775558
• Device Sequence Number: 15166147
• Product Code: PIF
• UDI-Device Identifier: 10814844001522
• UDI-Public: (01)10814844001522
• Combination Product (Y/N): N
• Initial Reporter State: IA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 04/14/2023
• Report Date (Section F): 04/14/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: INF0500-E
• Device Catalogue Number: INF0500-E
• Device Lot Number: CF2232101
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 04/20/2023
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/20/2023
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Female
• Date Report Sent to FDA: 04/14/2023