MAUDE Adverse Event Report: VYAIRE MEDICAL NEO-VERSO Y NEONATAL/INFANT AIRWAY ACCESS ADAPTER; CIRCUIT, BREATHING (W CONNECTOR, ADAPTOR, Y PIECE)

Model Number CSC300

Device Problem Break (1069)

Patient Problem Insufficient Information (4580)

Event Date 10/06/2021

Event Type  malfunction  

Event Description

Nurse was repositioning patient and adjusted airlife neo-verso y adapter on endotracheal tube and a piece of plastic broke off into her hand.Entire adapter needed to be changed.

• Brand Name: NEO-VERSO Y NEONATAL/INFANT AIRWAY ACCESS ADAPTER
• Type of Device: CIRCUIT, BREATHING (W CONNECTOR, ADAPTOR, Y PIECE)
• Manufacturer (Section D): VYAIRE MEDICAL; 26125 n. riverwoods blvd; mettawa IL 60045
• MDR Report Key: 12689610
• MDR Text Key: 278162489
• Report Number: 12689610
• Device Sequence Number: 1
• Product Code: CAI
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Type of Report: Initial
• Report Date: 10/14/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/25/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: CSC300
• Device Catalogue Number: CSC300
• Device Lot Number: 2007020001
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 10/14/2021
• Event Location: Hospital
• Date Report to Manufacturer: 10/25/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 21 DA