MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. 14"(36CM)APPX3.0ML, TRIFUSE EXT SET W/3 MICROCLAVE CLEAR¿,3 BCV,4-WAY NANOCLAVE¿; STOPCOCK, I.V. SET

Catalog Number	AC235
Medical Device Problem Codes	Disconnection (1171); Fluid/Blood Leak (1250); Fracture (1260)
Health Effect - Clinical Code	Chemical Exposure (2570)
Date of Event	01/01/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was returned for evaluation; however, testing has not yet been completed.Additional contact: (b)(6).
Event or Problem Description
The event occurred on an unspecified date and involved a 14"(36cm)appx3.0ml, trifuse ext set w/3 microclave clear¿,3 bcv,4-way nanoclave¿ stopcock(red ring).The patient reportedly disconnected from the device tubing.Upon entering the room, the nurse noticed that the tubing had snapped in half.The patient had unspecified chemotherapy going at the time in the lab port.The tubing that snapped was a trifuse connector on the side closest to the patient, beneath the lab port.There was chemotherapy exposure to the involved patient.
Additional Manufacturer Narrative
Investigation summary one (1) used.List #ac235, 14"(36cm)appx3.0ml, trifuse ext set w/3 microclave clear¿,3 bcv,4-way nanoclave¿ stopcock(red ring) was returned for evaluation.As received, one of tube was observed to be disconnected from an adapter bonded to the stopcock, the tube was visually inspected through uv light and not enough presence of solvent was confirmed.The od of the tube was measured finding within specification.No additional damage or anomalies were confirmed.Complaint can be confirmed.The probable cause was error during the manual bonding assembly process in the assembly plant.A device history lot # review could not be conducted because no lot number(s) was/were identified.Corrective and preventative actions are in process.

• Brand Name: 14"(36CM)APPX3.0ML, TRIFUSE EXT SET W/3 MICROCLAVE CLEAR¿,3 BCV,4-WAY NANOCLAVE¿
• 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: 24239769
• Report Number: 9617594-2026-00051
• Device Sequence Number: 9220320
• Product Code: FMG
• UDI-Device Identifier: 00887709122062
• UDI-Public: 00887709122062
• Combination Product (Y/N): N
• Initial Reporter State: TN
• 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,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/20/2026

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: AC235
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/19/2026
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/14/2026
• Supplement Date Received by Manufacturer: 04/29/2026
• Initial Report FDA Received Date: 02/02/2026
• Supplement Report FDA Received Date: 05/20/2026
• 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
• Concomitant Medical Products and Therapy/Usage Dates: UNSPECIFIED CHEMOTHERAPY
• Patient Sex: Unknown