MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. 6.5" (17 CM) APPX 1.2 ML, SMALLBORE TRIFUSE EXT SET W/3 MICROCLAVE¿ CLEAR, 0.2 M; 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	06/27/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device is not available for investigation.Without the return of the device a probable cause is unable to be determined.A device history review could not be completed due to the unknown lot number.
Event or Problem Description
The event involved a 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 the customer reported that the filter on the three-way device, running amino acids, was found to be leaking.The filter was replaced the following day.There was unknown patient involvement; harm was not reported as a consequence of this event.
Additional Manufacturer Narrative
Additional information: b5 was updated to clarify the new information received that there was patient involvement.
Event or Problem Description
The event involved a 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 the customer reported that the filter on the three way device, running amino acids, was found to be leaking.The filter was replaced the following day.There was patient involvement, but no harm was reported as a consequence of this event.

• Brand Name: 6.5" (17 CM) APPX 1.2 ML, SMALLBORE TRIFUSE EXT SET W/3 MICROCLAVE¿ CLEAR, 0.2 M
• 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: 22683085
• Report Number: 9617594-2025-01582
• Device Sequence Number: 15844228
• 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: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/24/2025

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: 07/04/2025
• Supplement Date Received by Manufacturer: 11/21/2025
• Initial Report FDA Received Date: 07/31/2025
• Supplement Report FDA Received Date: 11/24/2025
• 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
• Concomitant Medical Products and Therapy/Usage Dates: AMINO ACIDS, MFR UNK.
• Patient Sex: Unknown