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	11/21/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device has been requested for evaluation; however, it has not yet been received.
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 and it was reported that the transfer set was infusing parenteral nutrition leaking from rectangle 1.2-micron filter.There was patient involvement, and no patient harm/ adverse event reported.
Additional Manufacturer Narrative
Received one (1) used.List #mc330419, 102" (259 cm) appx 8.2 ml, pur standardbore/smallbore transfer set w/microclave® clear, dual check valve, 1.2 micron filter, luer lock; lot #14565775.No visual damages or anomalies were observed.The reported complaint of a leak could be confirmed.The returned sample was tested and a leak was observed on the spike filter.The probable cause of the leak is from the temporary or complete loss of hydrophobic properties.The lot history was reviewed, no nonconformities were identified that may have contributed to the reported complaint.

• 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: 23739179
• Report Number: 9617594-2025-02255
• Device Sequence Number: 18729485
• Product Code: FMG
• UDI-Device Identifier: 00887709087552
• UDI-Public: (01)00887709087552(17)300801(10)14565775
• 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): 01/27/2026

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: 14565775
• 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: 12/02/2025
• Supplement Date Received by Manufacturer: 01/22/2026
• Initial Report FDA Received Date: 12/08/2025
• Supplement Report FDA Received Date: 01/27/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/28/2025
• 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
• Concomitant Medical Products and Therapy/Usage Dates: PARENTERAL NUTRITION, UNK MFR
• Patient Sex: Unknown