MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. 60" (152 CM) APPX 1.9 ML, SMALLBORE EXT SET W/MICROCLAVE® CLEAR, 1.2 MICRON FILT; STOPCOCK, I.V. SET

Catalog Number	MC330174
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/01/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
B3 - date of event - the date of event is unknown, and 01 jan 2025 has been used as a placeholder.D9 - date returned to mfg - 15 jul 2025.The device has been received for evaluation.The investigation is pending completion.
Event or Problem Description
A complaint was received regarding a 60" (152 cm) appx 1.9 ml, smallbore ext set w/microclave® clear, 1.2 micron filter, 2 clamps, luer lock that experienced leakage.The reporter stated that the iv extension set is leaking from the clave near the lipid syringe.The event date and the status of the product at the time of event was unknown.There was unknown patient involvement.
Additional Manufacturer Narrative
Updated information: d9.Investigation summary: the complaint could not be confirmed by investigation.No product samples, pictures, or videos were received for investigation.Without the return of the used sample a comprehensive failure investigation cannot be performed, and a cause cannot be determined.The device history record could not be reviewed due to the unknown lot number.

• Brand Name: 60" (152 CM) APPX 1.9 ML, SMALLBORE EXT SET W/MICROCLAVE® CLEAR, 1.2 MICRON FILT
• 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: 22537764
• Report Number: 9617594-2025-01486
• Device Sequence Number: 7488231
• Product Code: FMG
• UDI-Device Identifier: 00887709079977
• UDI-Public: 00887709079977
• 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: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/30/2025

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: Other
• Device Catalogue Number: MC330174
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/19/2025
• Supplement Date Received by Manufacturer: 10/08/2025
• Initial Report FDA Received Date: 07/17/2025
• Supplement Report FDA Received Date: 10/30/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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: UNSPECIFIED SYRINGE, MFR UNK
• Patient Sex: Unknown