MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. 7" (18 CM) APPX 0.52 ML, SMALLBORE TRIFUSE EXT SET W/3 MICROCLAVE® CLEAR, 3 CLAM; STOPCOCK, I.V. SET

Catalog Number	MC330027
Medical Device Problem Codes	Fluid/Blood Leak (1250); Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/17/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation summary: the reported complaint of a tubing break could not be confirmed.Without the return of the sample or a photo/video a comprehensive review cannot be performed and a probable cause cannot be determined.No lot received for a device history record review.
Event or Problem Description
A complaint was received regarding a 7" (18 cm) appx 0.52 ml, smallbore trifuse ext set w/3 microclave® clear, 3 clamps, luer lock that experienced separation and leakage.The reporter stated that in the last week, they had an uptick of incidents in relation to the use of the bi fuse and tri fuse that they use from icu medical.Mom (medical mom) called out to report tubing had broken.Cvl was intact, though, through to where the trifuse connected.Rn assessed, and tubing was disconnected as it came out of tri-fuse bottom (tubing had pulled apart, not at a luer-lock, but within the tubing itself).A sterile cap change was done, a tubing change, as well as a pump change were done.The product have come in contact with the patient and/or staff member, yet the medication being administered, did not get on patient or staff skin or clothing.The chemo spill cleaned up per facility protocol.Thus, there was patient involvement and there was no staff or patient harm reported as a result of the event.

• Brand Name: 7" (18 CM) APPX 0.52 ML, SMALLBORE TRIFUSE EXT SET W/3 MICROCLAVE® CLEAR, 3 CLAM
• 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: 22097118
• Report Number: 9617594-2025-01111
• Device Sequence Number: 20925576
• Product Code: FMG
• UDI-Device Identifier: 00887709076419
• UDI-Public: 00887709076419
• Combination Product (Y/N): N
• Initial Reporter State: WI
• 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): 05/28/2025

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: MC330027
• 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: 04/28/2025
• Initial Report FDA Received Date: 05/28/2025
• 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