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

Model Number	39204
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	01/11/2022
Type of Reportable Event	Malfunction
Event or Problem Description
The 4in echobrite needle system used for nerve blocks leaked at an area just proximal of the needle and distal of the connection point.This allowed the nerve block medication to leak when pressure was applied.It was not evident when flushing of the line and only occurred when the needle was in the patient.
Event or Problem Description
The 4in echobrite needle system used for nerve blocks leaked at an area just proximal of the needle and distal of the connection point.This allowed the nerve block medication to leak when pressure was applied.It was not evident when flushing of the line and only occurred when the needle was in the patient.

• Brand Name: AVANOS
• Common Device Name: ANESTHESIA CONDUCTION KIT
• Manufacturer (Section D): AVANOS MEDICAL, INC.; 5405 windward parkway; alpharetta GA 30004
• MDR Report Key: 13497310
• Report Number: 13497310
• Device Sequence Number: 11857718
• Product Code: CAZ
• UDI-Device Identifier: 00193494392048
• UDI-Public: (01)00193494392048
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 01/17/2022
• Report Date (Section F): 01/17/2022

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: Health Professional
• Device Model Number: 39204
• Device Catalogue Number: EBL20100SG
• Device Lot Number: 30139427
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Event Location: Ambulatory Surgical Facility
• Date Report to Manufacturer: 02/09/2022
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/09/2022
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown
• Date Report Sent to FDA: 01/17/2022