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, S; 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	06/13/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The complaint of leaks on item mc330616 cannot be confirmed.Since 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 probable cause cannot be determined.
Event or Problem Description
The event involved a 102" (259 cm) appx 5.3 ml, transfer set w/microclave¿ clear, dual check valve, smallbore trifuse ext set w/2 microclave¿ clear (1 remv), 0.2 micron filter, 2 check valves, clamp (yellow), rotating luer.The filter of the device was reported to be leaking after the infusion set up had been hanging for 48hours.Total parenteral nutrition (tpn) d16% was running at 3ml/hr and smof lipids 0.9 ml/hr.There was no report of any human harm.

• Brand Name: 102" (259 CM) APPX 5.3 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: 22513902
• Report Number: 9617594-2025-01464
• Device Sequence Number: 18467534
• 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: Nurse
• Type of Report: Initial
• Report Date (Section B): 07/15/2025

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
• Device Lot Number: UNKNOWN
• 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: 06/16/2025
• Initial Report FDA Received Date: 07/15/2025
• 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: SMOF LIPIDS, MFR UNK; TOTAL PARENTERAL NUTRITION (TPN) D16%, MFR UNK
• Patient Sex: Unknown