MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. 6" (15 CM) APPX 1.3 ML, SMALLBORE QUADFUSE EXT SET W/4 MICROCLAVE® CLEAR, 4 CHEC; STOPCOCK, I.V. SET

Catalog Number	MC33634
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/11/2025
Type of Reportable Event	Malfunction
Event or Problem Description
An email was received regarding a smallbore quadfuse ext set w/4 microclave alleging a leak during patient use.It was reported that there was a leaking luer lock connection site to the quadfuse port.There was patient involvement and no patient harm.
Additional Manufacturer Narrative
Although the device was requested to be returned for evaluation, it has not been received.Without the returned device, a probable cause is unable to be determined.
Additional Manufacturer Narrative
D9 - date returned to mfr: 1/21/2026.Received one (1) used mc33634 smallbore quadfuse ext set w/4 microclave for inspection.No defects or anomalies observed.Testing was conducted for leakage by infusing through each port under pressure with a closed fluid path.There was no leakage observed.The male luer was measured and found to meet iso standards.The reported complaint was unable to be replicated or confirmed.

• Brand Name: 6" (15 CM) APPX 1.3 ML, SMALLBORE QUADFUSE EXT SET W/4 MICROCLAVE® CLEAR, 4 CHEC
• 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: 23507134
• Report Number: 9617594-2025-02142
• Device Sequence Number: 18648537
• Product Code: FMG
• UDI-Device Identifier: 00887709058088
• UDI-Public: 0887709058088
• 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): 03/11/2026

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: MC33634
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/21/2025
• Supplement Date Received by Manufacturer: 02/27/2026
• Initial Report FDA Received Date: 11/09/2025
• Supplement Report FDA Received Date: 03/11/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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