MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. 6.5" SMALLBORE TRIFUSE EXT SET W/3 MICROCLAVE® CLEAR, 0.2 MICRON FILTER, 2 CHECK; STOPCOCK, I.V. SET

Catalog Number	MC33927
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/12/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Additional reporter: (b)(6).Investigation summary: the reported complaint of a leak could not be confirmed.Without the return of the sample or a photo/video a comprehensive review cannot be performed, and a probable cause cannot be determined.No lot received for a device history review.
Event or Problem Description
Event occurred regarding 6.5" (17 cm) appx 1.2 ml, smallbore trifuse ext set w/3 microclave¿ clear, 0.2 micron filter, 2 check valves, 3 clamps, rotating luer where it was reported that the aads line and 3-way connector were found to be leaking.There was patient involvement, but no adverse event reported.

• Brand Name: 6.5" SMALLBORE TRIFUSE EXT SET W/3 MICROCLAVE® CLEAR, 0.2 MICRON FILTER, 2 CHECK
• 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. 22790 ; MX 22790
• Manufacturer Contact: reed covert ; 600 n. field dr.; lake forest, IL 60045 ; 2247062300
• MDR Report Key: 22874314
• Report Number: 9617594-2025-01730
• Device Sequence Number: 14874795
• Product Code: FMG
• UDI-Device Identifier: 00887709072213
• UDI-Public: 00887709072213
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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,Company Representative,Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 08/22/2025

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 Catalogue Number: MC33927
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/28/2025
• Initial Report FDA Received Date: 08/22/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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: Unknown