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

Model Number	A4197
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/24/2025
Type of Reportable Event	Malfunction
Event or Problem Description
After opening the tray we saw one of the two lidocaine ampules were broken this is the third tray in a row.

• Brand Name: PORTEX
• Common Device Name: ANESTHESIA CONDUCTION KIT
• Manufacturer (Section D): ICU MEDICAL, INC.; 4455 atherton dr; salt lake city UT 84123
• MDR Report Key: 22394206
• Report Number: 22394206
• Device Sequence Number: 13051489
• Product Code: CAZ
• UDI-Device Identifier: 20351688082425
• UDI-Public: (01)20351688082425
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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): 06/27/2025
• Report Date (Section F): 06/27/2025

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
• Operator of Device: Health Professional
• Device Model Number: A4197
• Device Lot Number: 6093796
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 07/03/2025
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 07/03/2025
• 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 Age: 78 YR
• Patient Sex: Male
• Date Report Sent to FDA: 06/27/2025