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

Model Number	PEXT-60NC
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	05/18/2020
Type of Reportable Event	Malfunction
Event or Problem Description
A total of 22 defective neoconnect 60" (152 cm) enfit extension sets (pext-60nc) were found between may 18th and june 15th, 2020.The tubing sets were from 4 different lot numbers, but the same di/product/reference #s.The defective lots were as follows: 20191126, 20191218, 20191230, and 20200110.The caregivers found the enfit feeding extension leaking at the patient connection.All have been checked to make sure they were secured appropriately with no "tilting" or misconnection noted.Also that they were not "too tight" or "loose".Some have been noted to be cracked at patient side securement.Once we had 2 extensions that were compromised, we immediately notified our nursing staff to watch for others.Because our staff was aware, they have been able to catch the leaks early on so infants receive their full calories as ordered.They have worked with materials to pull those lot numbers as defective batches have been found.Only four patients are included in this reports although there were more affected.Breakdown of lot #'s: 20191126 - 8 total.20191218 - 3 total.20191230 - 3 total.20200110 - 1 total.Unknown - 7 total (packaging not saved but connection/tubing was).

• 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: 10275436
• Report Number: 10275436
• Device Sequence Number: 2603414
• Product Code: KNT
• UDI-Device Identifier: 00817584012028
• UDI-Public: (01)00817584012028
• Combination Product (Y/N): N
• Initial Reporter State: UT
• 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): 07/10/2020
• Report Date (Section F): 07/10/2020

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: PEXT-60NC
• Device Catalogue Number: PEXT-60NC
• Device Lot Number: 20191126
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 07/15/2020
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 07/15/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 35 DA
• Patient Weight: 3
• Date Report Sent to FDA: 07/10/2020