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

Device Problems Leak/Splash (1354); Defective Device (2588)

Patient Problem Insufficient Information (4580)

Event Date 04/13/2023

Event Type  malfunction  

Event 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
• Type of Device: GASTROINTESTINAL TUBES WITH ENTERAL SPECIFIC CONNECTORS
• Manufacturer (Section D): ZEVEX , INC.; 4314 zevex park lane; salt lake city UT 84123
• MDR Report Key: 16775558
• MDR Text Key: 313640778
• Report Number: 16775558
• Device Sequence Number: 1
• Product Code: PIF
• UDI-Device Identifier: 10814844001522
• UDI-Public: (01)10814844001522
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 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
• Device Operator: 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
• Date Report Sent to FDA: 04/14/2023
• Event Location: Hospital
• Date Report to Manufacturer: 04/20/2023
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/20/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Sex: Female