MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. 12" (30 CM) APPX 2.4 ML, EXT SET W/MICROCLAVE®, CHECK VALVE; STOPCOCK, I.V. SET

Catalog Number	CH3557
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
Additional Manufacturer Narrative
The device has been requested for evaluation- it has not been received.The investigation is pending.
Event or Problem Description
An email was received with scar 000825 report regarding a 12" (30 cm) appx 2.4 ml, ext set w/microclave, check valve in which it was reported that there was a leak from breach in tubing line.This occurred during cell culture for a patient and no harm as reported.Manufacturing operators observed about 3ml of cell culture leak from the cell culture bag from the sample port line.

• Brand Name: 12" (30 CM) APPX 2.4 ML, EXT SET W/MICROCLAVE®, CHECK VALVE
• 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.
• Manufacturer Contact: reed covert ; 600 n. field dr.; lake forest, IL 60045 ; 2247062300
• MDR Report Key: 25164561
• Report Number: 9617594-2026-00454
• Device Sequence Number: 10566603
• Product Code: FMG
• UDI-Device Identifier: 00887709076389
• UDI-Public: (01)00887709076389(17)280801(10)13745189
• Combination Product (Y/N): N
• 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: User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• 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: CH3557
• Device Lot Number: 13745189
• 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: 01/02/2026
• Supplement Date Received by Manufacturer: 05/28/2026
• Initial Report FDA Received Date: 05/13/2026
• Supplement Report FDA Received Date: 06/17/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/29/2023
• 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: CELL CULTURE BAG, MFR UNKNOWN
• Patient Sex: Unknown