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

Model Number	PEXT-60NC
Health Effect - Clinical Code	Underdose (2542)
Date of Event	09/20/2020
Type of Reportable Event	Malfunction
Event or Problem Description
We are reporting two failures of the same product that happened within 1 week of each other: on (b)(6) 2020: the feeding tubing was found to have leaked the baby's feeding.After the feeding was complete and the pump turned off, the baby was fussy and acting hungry.It was then discovered his linens soaked in formula under the tubing and ng connection.Some formula was manually pushed through the tubing and it was all leaking out of a crack at the hub.The baby was re-fed through new tubing that was not cracked or leaking (lot# 20200227).On (b)(6) 2020: the feeding tube (neoconnect enteral extension set with enfit connector lot:20200110) leaked medolac feed where it connects to the patient's ng tube when being administered by pump.The health care provider caught the leak early so only a few ml was wasted and new tubing was obtained to deliver the remainder of the patient's feed.
Event or Problem Description
74we are reporting two failures of the same product that happened within 1 week of each other: the feeding tubing was found to have leaked the baby's feeding.After the feeding was complete and the pump turned off, the baby was fussy and acting hungry.It was then discovered his linens soaked in formula under the tubing and ng connection.Some formula was manually pushed through the tubing and it was all leaking out of a crack at the hub.The baby was re-fed through new tubing that was not cracked or leaking (lot# 20200227).Six days later.The feeding tube (neoconnect enteral extension set with enfit connector lot:20200110) leaked medolac feed where it connects to the patient's ng tube when being administered by pump.The health care provider caught the leak early so only a few ml was wasted and new tubing was obtained to deliver the remainder of the patient's feed.

• 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: 10711138
• Report Number: 10711138
• Device Sequence Number: 3482845
• 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,Followup
• Report Date (Section B): 10/08/2020
• Report Date (Section F): 10/08/2020

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: No Information
• Device Model Number: PEXT-60NC
• Device Catalogue Number: PEXT-60NC
• Device Lot Number: 20200227
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 10/21/2020
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/21/2020
• Supplement Report FDA Received Date: 10/26/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Date Report Sent to FDA: 10/08/2020