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, IV

Catalog Number	MC33687
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/04/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was returned for evaluation; however, testing has not yet been completed.
Event or Problem Description
It was reported that a 4" (10 cm) appx 0.89 ml, smallbore trifuse ext set w/3 microclave¿ clear, 2 check valve, 3 clamps (2 white, red), rotating luer was found to have become detached during patient use.The report states that "the customer stated that they have broken trifuse.Trifuse attached to cvl extension became spontaneously detached during mixed venous blood work.Unable to reattach trifuse.New trifuse obtained and reattached to cvl extension without incident." the event occurred in the paediatric icu (room# 11 at cvl extension site).The defective item was saved.There was no patient harm reported.
Additional Manufacturer Narrative
Received one used device for evaluation.As received, no physical damage or other anomalies observed.Connected the returned trifuse ext set to an approved icu mating device, no disconnect issue observed.Also verified the male luer to the iso standard gage.Unable to confirm the customer complaint of the trifuse spontaneously detached; unable to reattach trifuse; broken tri fuse.No mating device was returned.One photograph was provided by the customer, unable to confirm customer complaint from the photograph provided.Lot history reviewed; no nonconformities were identified that may have contributed to the reported complaint.

• Brand Name: 4" (10 CM) APPX 0.68 ML, SMALLBORE TRIFUSE EXT SET W/3 MICROCLAVE® CLEAR, 2 CHEC
• Common Device Name: STOPCOCK, IV
• 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: 21280464
• Report Number: 9617594-2025-00211
• Device Sequence Number: 18115819
• Product Code: FMG
• UDI-Device Identifier: 00887709064362
• UDI-Public: (01)00887709064362(17)291001(10)14169769
• 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,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/25/2025

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: 14169769
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/28/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/06/2025
• Supplement Date Received by Manufacturer: 02/26/2025
• Initial Report FDA Received Date: 01/30/2025
• Supplement Report FDA Received Date: 03/25/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/01/2024
• 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