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

Model Number PFTL6.5P-NC

Device Problem Leak/Splash (1354)

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

Event Date 02/02/2020

Event Type  malfunction  

Event Description

Began leaking at junction where tubing meets purple hub.Feeding tube had to be changed out.

• Brand Name: NEOCONNECT ENTERAL FEEDING TUBE
• Type of Device: TUBE, NASOGASTRIC
• Manufacturer (Section D): NEOMED, INC.; 100 londonberry ct. suite 112; woodstock GA 30188
• MDR Report Key: 9928224
• MDR Text Key: 186540187
• Report Number: 9928224
• Device Sequence Number: 1
• Product Code: FPD
• UDI-Device Identifier: 00817584011755
• UDI-Public: (01)00817584011755
• 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: 03/09/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/06/2020
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: PFTL6.5P-NC
• Device Catalogue Number: PFTL6.5P-NC
• Device Lot Number: 20170330
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 03/09/2020
• Event Location: Hospital
• Date Report to Manufacturer: 04/06/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 30 DA
• Patient Weight: 3