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

Model Number	PFTL6.5P-NC
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	02/02/2020
Type of Reportable Event	Malfunction
Event or Problem Description
Began leaking at junction where tubing meets purple hub.Feeding tube had to be changed out.

• Brand Name: NEOCONNECT ENTERAL FEEDING TUBE
• Common Device Name: TUBE, NASOGASTRIC
• Manufacturer (Section D): NEOMED, INC.; 100 londonberry ct. suite 112; woodstock GA 30188
• MDR Report Key: 9928224
• Report Number: 9928224
• Device Sequence Number: 2238510
• Product Code: FPD
• UDI-Device Identifier: 00817584011755
• UDI-Public: (01)00817584011755
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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): 03/09/2020
• Report Date (Section F): 03/09/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Operator of Device: No Information
• Device Model Number: PFTL6.5P-NC
• Device Catalogue Number: PFTL6.5P-NC
• Device Lot Number: 20170330
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 04/06/2020
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/06/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 30 DA
• Patient Weight: 3
• Date Report Sent to FDA: 03/09/2020