MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. 7" (18CM) APPX 0.37ML, SMALLBORE BIFUSE EXT SET W/2 MICROCLAVE® CLEAR, 2 CLAMPS,; STOPCOCK, I.V. SET

Catalog Number	MC3316
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/07/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device has been requested for evaluation; however, it has not yet been received.D4: only di provided as lot number is unknown.
Event or Problem Description
An event involved a 7" (18cm) appx 0.37ml, smallbore bifuse ext set w/2 microclave¿ clear, 2 clamps, rotating luer reported that the y extension tubing was leaking at site of cap/tubing junction, so infusion transferred from that y port to other and tubing clamped.They changed the y extension at cannula hub without any difficulties.There was patient involvement and no patient harm.
Additional Manufacturer Narrative
One used device was received for evaluation on 12/29/25.As received, one of the seals of the shuntless microcalve was observed to be stuck, no additional damage or anomalies were noted.No mating device was returned for evaluation.The set was primed and a leak from the damage shuntless microclave was noted, this was dissembled and spotty lubrication on spike and a significant damage at the top of the seal was noted.Complaint of leaks can be confirmed.The probable cause is typical due to incompatible mating device during use, dfu states: the clave connector is compatible with luers with an internal diameter (id) between 0.062" and 0.110".Lot history review could not be conducted because no lot number(s) was/were identified.

• Brand Name: 7" (18CM) APPX 0.37ML, SMALLBORE BIFUSE EXT SET W/2 MICROCLAVE® CLEAR, 2 CLAMPS,
• 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: 23641000
• Report Number: 9617594-2025-02216
• Device Sequence Number: 9765795
• Product Code: FMG
• UDI-Device Identifier: 00887709037458
• UDI-Public: 00887709037458
• 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,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/22/2026

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: MC3316
• Device Lot Number: UNKNOWN
• 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: 11/20/2025
• Supplement Date Received by Manufacturer: 01/20/2026
• Initial Report FDA Received Date: 11/25/2025
• Supplement Report FDA Received Date: 01/22/2026
• 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