MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. 102" (259 CM) APPX 8.2 ML, PUR STANDARDBORE/SMALLBORE TRANSFER SET W/MICROCLAVE®; STOPCOCK, I.V. SET

Catalog Number	MC330419
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/13/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device has been requested for evaluation; however, it has not yet been received.D4: only di provided as lot number is unknown.
Event or Problem Description
The event involved a 102" (259 cm) appx 8.2 ml, pur standardbore/smallbore transfer set w/microclave clear, dual check valve, 1.2 micron filter, luer lock reported that aads (amino acid plus dextrose solution) infusion infusing via syringe pump.In-line filter found leaking at shift onset.Aads infusion stopped, maintenance infusion changed.When infusing aads over syringe pump, the line should be changed q24h instead of q96h.The filter never lasts 96 hours without leaking.There was patient involvement and no reported patient harm.
Additional Manufacturer Narrative
One used device was returned for investigation.A device history review (dhr) could not be conducted because no lot number(s) was/were identified.The device was visually inspected.There were no anomalies noted upon visual inspection.As received, the filter vents on the 1.2 micron filter were wetted out with prior infuscate.The set was leak tested per product specifications.There was leakage from the inlet and outlet filter vents of the 1.2 micron filter.The reported complaint can be confirmed.The probable cause of leakage is due to a temporary or complete loss of hydrophobic properties of the filter vent material due to an infuscate interaction during use.The probable cause of leakage is due to a temporary or complete loss of hydrophobic properties of the filter vent material due to an infuscate interaction during use.

• Brand Name: 102" (259 CM) APPX 8.2 ML, PUR STANDARDBORE/SMALLBORE TRANSFER SET W/MICROCLAVE®
• 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: 23602352
• Report Number: 9617594-2025-02192
• Device Sequence Number: 18453981
• Product Code: FMG
• UDI-Device Identifier: 00887709087552
• UDI-Public: 00887709087552
• 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,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/15/2025

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: MC330419
• Device Lot Number: UNKNOWN
• 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: 11/17/2025
• Supplement Date Received by Manufacturer: 12/10/2025
• Initial Report FDA Received Date: 11/20/2025
• Supplement Report FDA Received Date: 12/15/2025
• 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
• Concomitant Medical Products and Therapy/Usage Dates: AMINO ACID PLUS DEXTROSE SOLUTION, UNK MFR.; SYRINGE PUMP.
• Patient Sex: Unknown