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

Model Number EXT-60YNC

Device Problems Crack (1135); Fluid/Blood Leak (1250)

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

Event Date 07/28/2020

Event Type  malfunction  

Event Description

Baby was receiving feeds via extension tube and the device was found leaking.Nurse discovered that the leak was caused by a crack at the connector part of the tubing.Manufacturer response for bifurcated enteral extension set, neoconnect (per site reporter): they have referred case to their quality department for review.

• Brand Name: NEOCONNECT ENTERAL EXTENSION SET
• Type of Device: TUBES, GASTROINTESTINAL (AND ACCESSORIES)
• Manufacturer (Section D): NEOMED, INC.; 100 londonderry ct. suite 112; woodstock GA 30188
• MDR Report Key: 10501828
• MDR Text Key: 205950023
• Report Number: 10501828
• Device Sequence Number: 1
• Product Code: KNT
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 08/21/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: EXT-60YNC
• Device Catalogue Number: EXT-60YNC
• Device Lot Number: 20190619
• 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: 08/21/2020
• Event Location: Hospital
• Date Report to Manufacturer: 09/08/2020
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/08/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1