MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. 7" 18CM APPX0.52ML SMALLB TRIFUSE EXT SET 3 MICROCLAVE CLEAR 3 CLAMPS LUER LOCK; STOPCOCK, I.V. SET

Catalog Number	MC330027
Medical Device Problem Codes	Disconnection (1171); Fluid/Blood Leak (1250)
Health Effect - Clinical Code	Chemical Exposure (2570)
Date of Event	11/25/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The reported complaint of disconnection could not be confirmed.Without the return of the sample or any photo/video, a comprehensive review cannot be performed and a probable cause cannot be determined.The device history record could not be reviewed as a lot number was not identified.
Event or Problem Description
The event occurred on various dates in 2024 and involved a 7" (18 cm) appx 0.52 ml, smallbore trifuse ext set w/3 microclave® clear, 3 clamps, luer lock.The trifuse reportedly did not thread tightly and pulled right off with little effort.Multiple staff members reported the same issue totaling five incidents approximately between 25nov2024 and 13ec2024.The reported issue was suspect for a chemo spill, but the device was discarded with the spill.There was no report of any human harm.This emdr represents five of the same/similar occurrences with no differing specific details across the incidents.

• Brand Name: 7" 18CM APPX0.52ML SMALLB TRIFUSE EXT SET 3 MICROCLAVE CLEAR 3 CLAMPS LUER LOCK
• 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: 21107360
• Report Number: 9617594-2025-00037
• Device Sequence Number: 8153772
• Product Code: FMG
• UDI-Device Identifier: 00887709076419
• UDI-Public: (01)00887709076419
• 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
• Type of Report: Initial
• Report Date (Section B): 01/08/2025

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: UNKNOWN
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/13/2024
• Initial Report FDA Received Date: 01/08/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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: Reuse
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: UNSPECIFIED CHEMOTHERAPY, MFR UNK
• Patient Sex: Unknown