MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. 102" (259 CM) APPX 8.3 ML EXT SET BIFUSE PUR STANDARDBORE/SMALLBORE W/CLAVE¿ CLE; STOPCOCK, I.V. SET

Catalog Number	MC330716
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/09/2025
Type of Reportable Event	Malfunction
Event or Problem Description
An event involved a 102" (259 cm) appx 8.3 ml ext set bifuse pur standardbore/smallbore w/clave¿ clear, spiros¿ w/red cap, dual check valve, 1.2 micron filter, luer lock reported that the 1.2-micron filter adjacent to the 2-way valve leaking.There was unknown patient involvement and unknown patient harm / injury reported.
Additional Manufacturer Narrative
The device is available for evaluation; however, has not been received.Additional reporter details: (b)(6).
Additional Manufacturer Narrative
Additional information d9 section.Complaint of leaks on item mc330716 cannot be confirmed.Since no product samples, pictures, or videos were received for investigation.Without the return of the used sample, a comprehensive failure investigation cannot be performed, and probable cause cannot be determined.Lot history review was conducted and no non-conformities were found that would have led to the reported condition on the complaint.
Additional Manufacturer Narrative
B5 - describe event or problem - updated with additional information.
Event or Problem Description
An event involved a 102" (259 cm) appx 8.3 ml ext set bifuse pur standardbore/smallbore w/clave¿ clear, spiros¿ w/red cap, dual check valve, 1.2 micron filter, luer lock reported that the 1.2-micron filter adjacent to the 2-way valve leaking.No patient harm reported.Yes, patient involved.

• Brand Name: 102" (259 CM) APPX 8.3 ML EXT SET BIFUSE PUR STANDARDBORE/SMALLBORE W/CLAVE¿ CLE
• 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: 23799933
• Report Number: 9617594-2025-02307
• Device Sequence Number: 9360388
• Product Code: FMG
• UDI-Device Identifier: 00887709127364
• UDI-Public: (01)00887709127364(17)300501(10)14425342
• 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,User Facility,Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/02/2026

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: MC330716
• Device Lot Number: 14425342
• 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: 12/10/2025
• Supplement Date Received by Manufacturer: 02/24/2026; 02/24/2026
• Initial Report FDA Received Date: 12/14/2025
• Supplement Report FDA Received Date: 03/06/2026; 04/03/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/27/2025
• 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