MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. 7" (18 CM) APPX 1.4 ML, SMALLBORE QUADFUSE EXT SET W/4 MICROCLAVE® CLEAR, 0.2 MI; STOPCOCK, I.V. SET

Catalog Number	MC33928
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/24/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device is not available for investigation.Without the return of the device a probable root cause is unable to be determined.The dhr was reviewed and no nonconformities were found that would have led to the reported complaint.(b)(6).(b)(4).
Event or Problem Description
The event involved a 7inch (18 cm) appx 1.4 ml, smallbore quadfuse ext set w4 microclave clear, 0.2 micron filter, 3 check valves, 4 clamps, rotating luer, and it was reported that filter on 4-way connector found to be leaking during hourly checks.

• Brand Name: 7" (18 CM) APPX 1.4 ML, SMALLBORE QUADFUSE EXT SET W/4 MICROCLAVE® CLEAR, 0.2 MI
• 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: 25530603
• Report Number: 9617594-2026-00615
• Device Sequence Number: 9358883
• Product Code: FMG
• UDI-Device Identifier: 00887709072220
• UDI-Public: (01)00887709072220(17)300201(10)14300012
• 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,User Facility,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 06/17/2026

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: MC33928
• Device Lot Number: 14300012
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/29/2026
• Initial Report FDA Received Date: 06/17/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/06/2025
• 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