MAUDE Adverse Event Report: NEOMED, INC. ENFIT NEOCONNECT; TUBE, FEEDING

Device Problem Leak/Splash (1354)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 05/06/2020

Event Type  malfunction  

Event Description

Device leaking from connection site.

• Brand Name: ENFIT NEOCONNECT
• Type of Device: TUBE, FEEDING
• Manufacturer (Section D): NEOMED, INC.; 100 londonderry ct, suite 112; woodstock GA 30188
• MDR Report Key: 10211404
• MDR Text Key: 196944253
• Report Number: 10211404
• Device Sequence Number: 1
• Product Code: FPD
• 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: 06/10/2020,05/26/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/30/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 06/10/2020
• Date Report to Manufacturer: 06/30/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1