MAUDE Adverse Event Report: AVANOS MEDICAL, INC. AVANOS; ANESTHESIA CONDUCTION KIT

Model Number 39207

Device Problem Blocked Connection (2888)

Patient Problem Insufficient Information (4580)

Event Date 03/10/2022

Event Type  malfunction  

Event Description

While attempting to flush the line in preparation for a nerve block the junction between the needle and where it meets the tubing is blocked off.

• Brand Name: AVANOS
• Type of Device: ANESTHESIA CONDUCTION KIT
• Manufacturer (Section D): AVANOS MEDICAL, INC.; 5405 windward parkway; alpharetta GA 30004
• MDR Report Key: 14407120
• MDR Text Key: 291731044
• Report Number: 14407120
• Device Sequence Number: 1
• Product Code: CAZ
• UDI-Device Identifier: 00193494392079
• UDI-Public: (01)00193494392079
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 04/27/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/16/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 39207
• Device Catalogue Number: EBL22050SG
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 04/27/2022
• Event Location: Ambulatory Surgical Facility
• Date Report to Manufacturer: 05/16/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1