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 Code	Disconnection (1171)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/13/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device is available for evaluation; however, it has not yet been received.
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 it was reported upon tracing lines at 19:30 it was noticed the lipid tubing was disconnected from the trifuse.When inspecting further the port on the trifuse was broken in and located in the trifuse.New lipid tubing was primed with new lipid syringe and new trifuse was primed/changed out for patient.There was patient involvement, and no injury reported.
Additional Manufacturer Narrative
Additional information in a2, a3, b5, d9, h10 and new attachment section.
Event or Problem Description
Additional information was received via medsun medwatch mandatory and voluntary report with uf/importer report # (b)(4) on 15-jan-2025.The report stated: "upon tracing lines, we noticed the lipid tubing was disconnected from the trifuse.When inspecting further, the port on the trifuse was broken in and located in the trifuse.New lipid tubing were primed with new lipid syringe and new trifuse was primed/changed out for patient.¿ the report was completed by mike ligocki, a health professional.The contact person is (b)(6) hospital.The event date is dec-2024, and the date reported is jan-2025 as initial report.The event occurred at the hospital user facility.The suspected medical device was a trifuse with item number mc330027 and lot number 14104635 with a common device name stopcock, i.V.Set with procode fmg.Expiry date unknown.This a single-use device and was not reprocessed and reused on a patient and this device was never serviced by a third-party servicer.The sample is available for evaluation.There was patient involvement, a 1-month-old female and the race is white.No patient harm and delay in therapy.
Additional Manufacturer Narrative
Investigation summary one (1) used list# mc330027, 7" (18 cm) appx 0.52 ml, smallbore trifuse ext set w/3 microclave¿ clear, 3 clamps, luer lock was received and visually inspected.As received, the tubing was separated from the trifuse connector.The dimensions of the separated components were measured and found to meet product specifications.The separated components were examined under a microscope.Evidence of residual torn tubing within the trifuse bond pocket.Tubing is torn, not clean cut.No additional physical damage or other anomalies were observed.The lot history was reviewed, no nonconformities were identified that may have contributed to the reported complaint.The customer complaint of the tubing disconnected from the trifuse and when inspecting further the port on the trifuse was broken is confirmed.The probable cause is unintentional pulling force.

• 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: 21154175
• Report Number: 9617594-2025-00099
• Device Sequence Number: 13045188
• Product Code: FMG
• UDI-Device Identifier: 00887709076419
• UDI-Public: (01)00887709076419(17)290801(10)14104635
• Combination Product (Y/N): N
• Initial Reporter State: UT
• 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,Followup
• Report Date (Section B): 04/01/2025

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: 14104635
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/18/2024
• Supplement Date Received by Manufacturer: 01/15/2025; 03/06/2025
• Initial Report FDA Received Date: 01/14/2025
• Supplement Report FDA Received Date: 02/12/2025; 04/01/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/01/2024
• 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
• Concomitant Medical Products and Therapy/Usage Dates: LIPIDS, UNK MFR.
• Patient Age: 1 MO
• Patient Sex: Female