MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. 9.5" SMALLBORE TRIFUSE EXT SET W/3 MICROCLAVE® CLEAR,NANOCLAVE® (RED RING); STOPCOCK, I.V. SET

Catalog Number	A1141
Medical Device Problem Code	Disconnection (1171)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/31/2026
Type of Reportable Event	Malfunction
Event or Problem Description
An event was reported involving 9.5" smallbore trifuse ext set w/3 microclave® clear,nanoclave® (red ring), 3 check valves, 4 clamps (yellow, light green, 2 white), luer lock was reported that the patient has a picc and had a tri-set attached, with running lines through two of the ports.One was clamped and capped.Green port was found in the patient's bed, had come apart from the tri-set.It was reported that, event occurred that reached the patient but was not followed by patient harm.
Additional Manufacturer Narrative
The device has been received for evaluation; however, investigation is not yet complete.

• Brand Name: 9.5" SMALLBORE TRIFUSE EXT SET W/3 MICROCLAVE® CLEAR,NANOCLAVE® (RED RING)
• 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: 25566310
• Report Number: 9617594-2026-00663
• Device Sequence Number: 13332175
• Product Code: FMG
• UDI-Device Identifier: 00887709069343
• UDI-Public: (01)00887709069343
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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: User Facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/13/2026

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: A1141
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/09/2026
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/02/2026
• Supplement Date Received by Manufacturer: 07/08/2026
• Initial Report FDA Received Date: 06/19/2026
• Supplement Report FDA Received Date: 07/13/2026
• 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: LIPIDS INFUSING, UNK MFR.; TPN, UNK MFR.
• Patient Sex: Unknown