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

Model Number	FTM5.0P-EO
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	07/22/2018
Type of Reportable Event	Malfunction
Event or Problem Description
The hard plastic port at the top of the feeding tube has a small cut/tear.There is a small black arrow drawn onto the device pointing at the cut.This cut causes the device to leak.

• Brand Name: NEOMED ENTERAL FEEDING TUBE
• Common Device Name: TUBE, NASOGASTRIC
• Manufacturer (Section D): NEOMED, INC.; 100 londonderry ct; suite 112; woodstock GA 30188
• MDR Report Key: 7826147
• Report Number: 7826147
• Device Sequence Number: 2446801
• Product Code: BSS
• UDI-Device Identifier: 00817584010253
• UDI-Public: (01)00817584010253
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 07/30/2018
• Report Date (Section F): 07/30/2018

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: FTM5.0P-EO
• Device Catalogue Number: FTM5.0P-EO
• Device Lot Number: 20180620
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 08/29/2018
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/29/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 15 DA
• Date Report Sent to FDA: 07/30/2018