MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. 102" (259 CM) APPX 5.3 ML, TRANSFER SET W/MICROCLAVE¿ CLEAR, DUAL CHECK VALVE,; STOPCOCK, I.V. SET

Catalog Number	MC330616
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/01/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that on an unspecified date in april with regards to the transfer set with microclave¿ clear, dual check valve, smallbore trifuse ext set w/2 microclave¿ clear ,0.2 micron filter, 2 check valves, clamp (yellow), rotating luer, the reporter stated that they were having trouble with several leaking from the filter.There was unknown patient involvement and unknown harm reported.
Additional Manufacturer Narrative
Investigation including root cause analysis is in progress.A supplemental mdr will be filed as necessary when additional reportable information becomes available.
Additional Manufacturer Narrative
Investigation summary one used device was returned for evaluation.The filter vents on the 0.2 micron filter were wetted out with prior infusate.The set was leak tested per product specifications.There was no leakage.Although the complaint could not be replicated, it can be confirmed based on the saturated filters.The probable cause of the leakage is due to a temporary or complete loss of hydrophobic properties of the filter vent material due to an infusate interaction during use.A device history review could not be conducted because no lot number(s) was/were identified.

• Brand Name: 102" (259 CM) APPX 5.3 ML, TRANSFER SET W/MICROCLAVE¿ CLEAR, DUAL 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 ; MX
• Manufacturer Contact: reed covert ; 600 n. field dr.; lake forest, IL 60045 ; 2247062300
• MDR Report Key: 22135918
• Report Number: 9617594-2025-01146
• Device Sequence Number: 8354230
• Product Code: FMG
• UDI-Device Identifier: 00887709097087
• UDI-Public: 00887709097087
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/24/2025

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: MC330616
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/23/2025
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/06/2025
• Supplement Date Received by Manufacturer: 06/27/2025
• Initial Report FDA Received Date: 06/03/2025
• Supplement Report FDA Received Date: 07/24/2025
• 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
• Patient Sex: Unknown