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	Separation Problem (4043)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/17/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
F2 - uf/importer report # (b)(4).One used sample list # mc330027, 7" connected to 3, unknown, 10ml syringe were returned for evaluation.As received one of the tubes was observed to be separated from shuntless microclave.The tube was analyzed through uv light and insufficient solvent coverage on tube was confirmed.The tube and the inner pocket were found to be within specification.Complaint of separation can be confirmed based.The probable cause is due to insufficient solvent applied during manual process assembly at manufacturing.The lot history was reviewed and no nonconformities were identified that may have contributed to the reported complaint.
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 tt was reported that the device had a drawing labs from a central line using trifuse then after drawing back my waste and clamping the tubing, the clave detached from the tubing of the trifuse.There was a patient involved but no harm adverse event reported.
Additional Manufacturer Narrative
Correction is in h10.

• 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: 20684426
• Report Number: 9617594-2024-01606
• Device Sequence Number: 17962280
• Product Code: FMG
• UDI-Device Identifier: 00887709076419
• UDI-Public: (01)00887709076419(17)281001(10)13803291
• 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,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/25/2025

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: MC330027
• Device Lot Number: 13803291
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/10/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/15/2024
• Supplement Date Received by Manufacturer: 10/15/2024
• Initial Report FDA Received Date: 11/14/2024
• Supplement Report FDA Received Date: 06/25/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/01/2023
• 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 Age: 11 YR
• Patient Sex: Female