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	11/16/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device is available for evaluation: it has not been received.The investigation is pending.
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.It was reported that the in-line filter was found leaking at shift onset.A syringe pump/microbore tubing used for aads infusion was used.There was patient involvement but no patient harm.
Additional Manufacturer Narrative
One used device was returned for investigation.The device was visually inspected, and no anomalies were noted.The set was primed as returned and a leak from the filter vent was confirmed.The complaint could be confirmed, and a probable root cause was according to dfu (directions for use)- ivfe (intravenous fat emulsion) or tna (total nutrient admixture) (3-in-1) solutions containing lipids must be administered using a 1.2-micron filter and sets with these filters should be changed at least every 24-hours.A device history record review could not be conducted because the lot number is unknown.D9 - date returned to mfg: 12/4/2025.
Additional Manufacturer Narrative
One used device was received for evaluation on 12/4/2025 and was connected to an unknown, 20 ml bd-syringe.As received aads solution residual was found.No physical damage or anomalies were observed.The set was primed as returned and a leak from the filter vent was confirmed.Complaint of leaks can be confirmed.The probable cause was due to a temporary or complete loss of hydrophobic properties of the filter vent material due to an infusate interaction during use; according to directions for use - ivfe or tna (3-in-1) solutions containing lipids must be administered using a 1.2-micron filter.Sets with these filters should be changed at least every 24-hours.Lot history review could not be conducted because no lot number(s) was/were identified.

• 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: 23707717
• Report Number: 9617594-2025-02234
• Device Sequence Number: 10629341
• Product Code: FMG
• UDI-Device Identifier: 00887709087552
• UDI-Public: (01)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,Company Representative
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 01/22/2026

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: MC330419
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/18/2025
• Supplement Date Received by Manufacturer: 12/19/2025; 01/20/2026
• Initial Report FDA Received Date: 12/03/2025
• Supplement Report FDA Received Date: 12/29/2025; 01/22/2026
• 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
• Concomitant Medical Products and Therapy/Usage Dates: AMINO ACID DEXTROSE SOLUTIONS, UNK MFR
• Patient Sex: Unknown