MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. De R.L. De C.V. 7" (18 cm) Appx 0.52 ml, Smallbore Trifuse Ext Set w/3 MicroClave® Clear, 3 Clam; Stopcock, I.V. Set

Catalog Number	MC330027
Medical Device Problem Code	Air/Gas in Device (4062)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/18/2026
Type of Reportable Event	Malfunction
Event or Problem Description
The event involved a 7" (18 cm) appx 0.52 ml, smallbore trifuse ext set w3 microclave clear, 3 clamps, luer lock.It was reported that during a lab blood draw from the patient's picc (peripherally inserted central catheter), the syringe filled with air instead of blood while the nurse was drawing back waste.The nurse observed that air was entering the line from the hub of the trifuse.The trifuse was immediately clamped and removed.No air reached the patient.The patient remained stable with no changes in vital signs or neurologic function, and no harm was reported.No issues were noted while priming the trifuse.
Additional Manufacturer Narrative
The device has been requested for evaluation; however, it has not yet been received.

• Brand Name: 7" (18 cm) Appx 0.52 ml, Smallbore Trifuse Ext Set w/3 MicroClave® Clear, 3 Clam
• Common Device Name: Stopcock, I.V. Set
• Manufacturer (Section D): ICU MEDICAL DE MEXICO, S. De R.L. De C.V.; avenida cuarzo no. 250; ensenada, b.cfa. NA 22790 ; MX 22790
• Manufacturer Contact: reed covert ; 951 calle amanecer; san clemente, CA 92673 ; +1(224)706-2300
• MDR Report Key: 50839449
• Report Number: 9617594-2026-01312
• Device Sequence Number: 18657061
• Product Code: FMG
• UDI-Device Identifier: 00887709076419
• Combination Product (Y/N): N
• Initial Reporter State: UT
• Initial Reporter Country: US
• PMA/510(K) Number: K964435
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 09/21/2026

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 Catalogue Number: MC330027
• Device Lot Number: 14921558
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/01/2026
• Initial Report FDA Received Date: 09/21/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/12/2026
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Female