MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. 4" SMALLBORE QUADFUSE EXT SET W/4 MICROCLAVE® CLEAR, 3 CHECK VALVES, 4 CLAMPS (3; STOPCOCK, I.V. SET

Catalog Number	MC33688
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/18/2025
Type of Reportable Event	Malfunction
Event or Problem Description
The event involved a 4" smallbore quadfuse ext set w/4 microclave® clear, 3 check valves, 4 clamps (3 white, red), rotating luer where it was reported that it appeared that quad fuse was backed up and started leaking lipids.The event occurred during use for patient at pediatric medicine.Thus, there was patient involvement, unknown human harm and unknown delay in therapy reported.
Additional Manufacturer Narrative
The device is available for evaluation- it has not been received.The investigation is pending.
Additional Manufacturer Narrative
Investigation summary: received one (1) used list# mc33688, 4" smallbore quadfuse ext set w/4 microclave® clear, 3 check valves, 4 clamps (3 white, red), rotating luer, as received, one of the microclaves was stuck down, also noticed seal damage, coring.No other anomalies observed.No mating devices were returned with the used sample.The returned sample was leak tested and a leak was confirmed.The returned used microclave had seal damage typical of access with an incompatible mating device.The customer complaint of leaking is confirmed.Dfu states: to avoid damage to the clave or syringes or male luers which may result in delays of medication administration and possible serious adverse events, users should confirm mating luers or syringes have an internal diameter range of 0.062¿ to 0.110¿.Check the internal diameter of the male-luer connector of the mating syringe prior to using it to access the clave.A device history record lot# review could not be conducted because no lot number(s) was/were identified.

• Brand Name: 4" SMALLBORE QUADFUSE EXT SET W/4 MICROCLAVE® CLEAR, 3 CHECK VALVES, 4 CLAMPS (3
• 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: 21414757
• Report Number: 9617594-2025-00322
• Device Sequence Number: 9345685
• Product Code: FMG
• UDI-Device Identifier: 00887709064379
• UDI-Public: 00887709064379
• 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: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 04/17/2025

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: MC33688
• 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: 01/21/2025
• Supplement Date Received by Manufacturer: 03/21/2025
• Initial Report FDA Received Date: 02/19/2025
• Supplement Report FDA Received Date: 04/17/2025
• 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
• Concomitant Medical Products and Therapy/Usage Dates: LIPIDS, MFR UNK.
• Patient Sex: Unknown