MAUDE Adverse Event Report: AVANOS MEDICAL, INC. AVANOS; CATHETER, CONDUCTION, ANESTHETIC

Model Number	13539
Health Effect - Clinical Code	Eye Pain (4467)
Date of Event	05/01/2025
Type of Reportable Event	Malfunction
Event or Problem Description
Rn opened avanos on-q antimicrobial expansion kit to sterile back table.Rn holding kit open for scrub tech to grab supplies.Another rn reported hearing "pop" sound and the sheathed introducer in package sling-shotted out of package into the first rn's eye.Rn used eyewash station and examined eye.Mild pain present but no other injuries noted.

• Brand Name: AVANOS
• Common Device Name: CATHETER, CONDUCTION, ANESTHETIC
• Manufacturer (Section D): AVANOS MEDICAL, INC.; 741 n meadowcroft ave; pittsburgh PA 15216
• MDR Report Key: 22885309
• Report Number: 22885309
• Device Sequence Number: 4939854
• Product Code: BSO
• UDI-Device Identifier: 00193494135393
• UDI-Public: (01)00193494135393
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• 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): 08/18/2025
• Report Date (Section F): 08/18/2025

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
• Device Model Number: 13539
• Device Catalogue Number: PM040-A
• Device Lot Number: 30311250
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 08/25/2025
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/25/2025
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown
• Date Report Sent to FDA: 08/18/2025