MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. 5" (13 CM) APPX 0.74 ML, PUR YELLOW SMALLBORE TRIFUSE EXT SET W/3 CLAVE¿ CLEAR,; STOPCOCK, I.V. SET

Catalog Number	MC330710
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/01/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
One photo was provided for evaluation; the photo confirms fluid leaking from the tubing connection to the luer.Lot history review was conducted and no relevant nonconformities observed that would have contributed to this complaint.
Event or Problem Description
The event occurred on an unspecified date and involved a 5" (13 cm) appx 0.74 ml, pur yellow smallbore trifuse ext set w/3 clave¿ clear, 3 anti-siphon valve, 3 clamps (blue, yellow, white), spin luer where the customer reported a defective tubing where there was unknown patient involvement; harm was not reported as consequence of this event.Investigation did confirm a leak.

• Brand Name: 5" (13 CM) APPX 0.74 ML, PUR YELLOW SMALLBORE TRIFUSE EXT SET W/3 CLAVE¿ CLEAR,
• 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: 22034603
• Report Number: 9617594-2025-01021
• Device Sequence Number: 9484642
• Product Code: FMG
• UDI-Device Identifier: 00887709126794
• UDI-Public: (01)00887709126794(17)290801(10)14114331
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 05/16/2025

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: MC330710
• Device Lot Number: 14114331
• 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: 05/15/2025
• Initial Report FDA Received Date: 05/16/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/01/2024
• 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