MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. 5" (13 CM) APPX 0.46 ML, SMALLBORE TRIFUSE EXT SET W/3 MICROCLAVE®, 3 CLAMPS, LU; STOPCOCK, I.V. SET

Catalog Number	B33877
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/08/2025
Type of Reportable Event	Malfunction
Event or Problem Description
A complaint was received regarding a 5" (13 cm) appx 0.46 ml, smallbore trifuse ext set w/3 microclave®, 3 clamps, luer lock that experienced breakage.The report stated that the tip of trifuse broke off completely.The events occurred on june 8, 2025.There was unknown patient involvement.That the defects can only be discovered when they are in use.There were no physical injuries related to the defects.The lot number are unknown, as the defects are noticed after the devices are in use and the packaging is discarded.
Additional Manufacturer Narrative
D4 and h4 the lot#, expiration date, and manufacture date are unknown.The device has been requested for evaluation- it has not been received.The investigation is pending.
Additional Manufacturer Narrative
D9 - device available for evaluation: no.The complaint could not be confirmed by the investigation.No product samples, pictures, or videos were received for investigation.Without the return of the used sample, a comprehensive failure investigation cannot be performed, and a cause cannot be determined.The device history review (dhr) could not be reviewed due to the unknown lot number.

• Brand Name: 5" (13 CM) APPX 0.46 ML, SMALLBORE TRIFUSE EXT SET W/3 MICROCLAVE®, 3 CLAMPS, LU
• 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: 22487767
• Report Number: 9617594-2025-01442
• Device Sequence Number: 12808141
• Product Code: FMG
• UDI-Device Identifier: 00887709085626
• UDI-Public: 00887709085626
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/03/2025

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: B33877
• 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: 06/13/2025
• Supplement Date Received by Manufacturer: 07/21/2025
• Initial Report FDA Received Date: 07/11/2025
• Supplement Report FDA Received Date: 10/03/2025
• 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