MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. 7" (18 CM) APPX 0.52 ML, SMALLBORE TRIFUSE EXT SET W/3 MICROCLAVE¿ CLEAR, 3 CLAM; STOPCOCK I.V. SET

Catalog Number	MC330027
Medical Device Problem Codes	Crack (1135); Disconnection (1171)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/08/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device has been received for evaluation, however, the investigation is not complete.
Event or Problem Description
The event involved a 7" (18 cm) appx 0.52 ml, smallbore trifuse ext set w/3 microclave¿ clear, 3 clamps, luer lock where the customer reported that the trifuse became disconnected from the lipid line as the connector had broken.The status of the product at the time of the event was use on a patient but harm was not reported as a consequence of this event.
Additional Manufacturer Narrative
Received one used.List #mc330027, 7" (18 cm) appx 0.52 ml, smallbore trifuse ext set w/3 microclave¿ clear, 3 clamps, luer lock; lot #14012443.No visual damages or anomalies were observed.The reported complaint of a disconnection could not be confirmed.The returned sample was tested and no disconnections were observed.The lot history was reviewed; no nonconformities were identified that may have contributed to the reported complaint.

• Brand Name: 7" (18 CM) APPX 0.52 ML, SMALLBORE TRIFUSE EXT SET W/3 MICROCLAVE¿ CLEAR, 3 CLAM
• 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: 21988804
• Report Number: 9617594-2025-00946
• Device Sequence Number: 20925299
• Product Code: FMG
• UDI-Device Identifier: 00887709076419
• UDI-Public: (01)00887709076419(17)290501(10)14012443
• Combination Product (Y/N): N
• 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,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/26/2025

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: MC330027
• Device Lot Number: 14012443
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/23/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/10/2025
• Supplement Date Received by Manufacturer: 06/02/2025
• Initial Report FDA Received Date: 05/08/2025
• Supplement Report FDA Received Date: 06/26/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/01/2024
• 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