MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. 4" (10 CM) APPX 0.68 ML, SMALLBORE TRIFUSE EXT SET W/3 MICROCLAVE® CLEAR, 2 CHEC; STOPCOCK, I.V. SET

Catalog Number	MC33687
Medical Device Problem Code	No Flow (2991)
Health Effect - Clinical Code	Hemorrhage/Blood Loss/Bleeding (1888)
Date of Event	08/05/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device has been received for evaluation.The investigation is pending completion.
Event or Problem Description
Event occurred regarding a 4" (10 cm) smallbore trifuse ext set w/3 microclave¿ clear, 2 check valve, 3 clamps (2 white, red), rotating luer where they stated in the report that "patient seen at 0600 for hourly check, right shoulder and blanket noted to have blood on it.Blood backing up into trifuse extension and blood around extension pieces.Everything connected.Extension trifuse exchanged and infusing well without issues now." there was patient involvement, but no patient harm was reported.
Additional Manufacturer Narrative
One used device was returned for evaluation; no visual damages or anomalies were observed.The reported complaint of back flow could be confirmed.The returned sample was tested and a small tear was found in the tubing.The probable cause is from an unintentional pulling force during use.Lot history review could not be conducted because no lot number(s) was/were identified.

• Brand Name: 4" (10 CM) APPX 0.68 ML, SMALLBORE TRIFUSE EXT SET W/3 MICROCLAVE® CLEAR, 2 CHEC
• 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: 22951863
• Report Number: 9617594-2025-01787
• Device Sequence Number: 18550890
• Product Code: FMG
• UDI-Device Identifier: 00887709064362
• UDI-Public: 00887709064362
• 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): 10/09/2025

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: MC33687
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/13/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/06/2025
• Supplement Date Received by Manufacturer: 09/15/2025
• Initial Report FDA Received Date: 09/03/2025
• Supplement Report FDA Received Date: 10/09/2025
• 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