MAUDE Adverse Event Report: NEOMED, INC. NEOCONNECT ENTERAL EXTENSION SET; TUBES, GASTROINTESTINAL (AND ACCESSORIES)

Model Number	EXT-60YNC
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	09/02/2019
Type of Reportable Event	Malfunction
Event or Problem Description
Leaking noted at the female hub connector, approximately half way through feeding.

• Brand Name: NEOCONNECT ENTERAL EXTENSION SET
• Common Device Name: TUBES, GASTROINTESTINAL (AND ACCESSORIES)
• Manufacturer (Section D): NEOMED, INC.; 100 londonderry ct, suite 112; woodstock GA 30188
• MDR Report Key: 9699652
• Report Number: 9699652
• Device Sequence Number: 1742017
• Product Code: KNT
• UDI-Device Identifier: 00817584012035
• UDI-Public: (01)00817584012035
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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): 01/06/2020
• Report Date (Section F): 01/06/2020

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: EXT-60YNC
• Device Catalogue Number: EXT-60YNC
• Device Lot Number: 20190413
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 02/12/2020
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/12/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 41 DA
• Patient Weight: 1
• Date Report Sent to FDA: 01/06/2020