MAUDE Adverse Event Report: ICU MEDICAL, INC. PORTEX; TUBES, VIALS, SYSTEMS, SERUM SEPARATORS, BLOOD COLLECTION

Model Number	4645P-2
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/02/2025
Type of Reportable Event	Malfunction
Event or Problem Description
While drawing laboratory samples and placing the cap on an arterial blood gas (abg) syringe, blood was being pushed into the cap.The blood in the syringe suddenly expelled.Upon closer inspection, the abg syringe was found to be cracked.

• Brand Name: PORTEX
• Common Device Name: TUBES, VIALS, SYSTEMS, SERUM SEPARATORS, BLOOD COLLECTION
• Manufacturer (Section D): ICU MEDICAL, INC.; 6000 nathan lane north; minneapolis MN 55442
• MDR Report Key: 23815560
• Report Number: 23815560
• Device Sequence Number: 10104582
• Product Code: JKA
• UDI-Device Identifier: 20351688005929
• UDI-Public: (01)20351688005929
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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): 12/05/2025
• Report Date (Section F): 12/05/2025

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: 4645P-2
• Device Lot Number: 6087307
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 12/16/2025
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 12/16/2025
• 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 Sex: Female
• Date Report Sent to FDA: 12/05/2025