MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. 127" (323 CM) APPX 9.7 ML, TRANSFER SET W/MICROCLAVE® CLEAR, DUAL CHECK VALVE, S; STOPCOCK, I.V. SET

Catalog Number	MC330523
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/05/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Received one (1) used mc330523 transfer set w/clave, smallbore trifuse ext set, 2-0.2 micron filters for inspection.As received, the 0.2 micron filter on the green line was wetted out with prior infusate.The set was leak tested per product specifications.There was leakage from the inlet filter vent.The reported complaint of leakage 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 infusate interaction during use.The lot history was reviewed, no nonconformities were identified that may have contributed to the reported complaint.
Event or Problem Description
The event involved a 127" (323 cm) appx 9.7 ml, transfer set w/microclave® clear, dual check valve, smallbore clear/pur yellow trifuse ext set w/2 microclave® clear (yellow, green rings), 2-0.2 micron filters, rotating luer where it was reported that the green filter on the trifuse set was leaking.The level of harm was minimal and patient's impact to the incident was risk of infection.There was no serious harm reported.There was unexpected or prolonged care.Thus, there was patient involvement and no harm reported.

• Brand Name: 127" (323 CM) APPX 9.7 ML, TRANSFER SET W/MICROCLAVE® CLEAR, DUAL CHECK VALVE, S
• 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: 21779236
• Report Number: 9617594-2025-00644
• Device Sequence Number: 7844608
• Product Code: FMG
• UDI-Device Identifier: 00887709092020
• UDI-Public: (01)00887709092020(17)300101(10)14283829
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 04/04/2025

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: MC330523
• Device Lot Number: 14283829
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/18/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/07/2025
• Initial Report FDA Received Date: 04/04/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/01/2025
• 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
• Patient Sex: Unknown