MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. 4" (10 CM) APPX 0.89 ML, SMALLBORE TRIFUSE EXT SET W/3 MICROCLAVE¿ CLEAR, 2 CHEC; STOPCOCK, I.V. SET

Catalog Number	MC33687
Medical Device Problem Codes	Fluid/Blood Leak (1250); Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/26/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Two (2) photos were returned by the customer showing the area of leakage.Received one (1) used mc33687 smallbore trifuse ext set for inspection.One (1) of the microclaves of the male luer was not fully inserted into the female luer of the check valve.The threads of the female luer were exposed.The set was leak tested per product specifications.There was leakage from the incomplete connection.The probable cause of the leakage is due to an incomplete insertion during manual assembly in ensenada.A device history review (dhr) lot # review could not be conducted because no lot number(s) was/were identified.
Additional Manufacturer Narrative
D4 and h4 the lot#, expiration date, and manufacture date are unknown.The device has been received for evaluation.The investigation is pending completion.
Event or Problem Description
A complaint was received regarding a 4" (10 cm) appx 0.89 ml, smallbore trifuse ext set w/3 microclave¿ clear, 2 check valve, 3 clamps (2 white, red), rotating luerthat experienced leakage.It was reported that patient with history of seizures and required sedation due to decompensation from day shift prior.Writer found a wet spot under the trifuse running the midazolam (for seizures and sedation) and the hydromorphone (sedation).The actual trifuse looked like it was damaged during the manufacturing process as the clave looks crooked where it's fused to the filter.This fuse was running midaz which was initiated for seizures and that night the patient had new eye deviation findings (though no true signs of seizures).Do not know if this is connected to the midaz fuse leaking.The date of incident was on (b)(6) 2025 at 08:00:00 in cccu (cardiac critical care unit).The defective item was saved and is available for investigation.Photos of the actual defective item were provided.The status of the product at the time of the event was used on a patient.The sample does not contain any hazardous materials.There was no patient harm and no delay in therapy.

• Brand Name: 4" (10 CM) APPX 0.89 ML, SMALLBORE TRIFUSE EXT SET W/3 MICROCLAVE¿ CLEAR, 2 CHEC
• 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: 22101652
• Report Number: 9617594-2025-01116
• Device Sequence Number: 20675814
• Product Code: FMG
• UDI-Device Identifier: 00887709064362
• UDI-Public: 00887709064362
• 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: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 07/16/2025

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: MC33687
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/07/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/29/2025
• Supplement Date Received by Manufacturer: 06/20/2025
• Initial Report FDA Received Date: 05/28/2025
• Supplement Report FDA Received Date: 07/17/2025
• 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
• Concomitant Medical Products and Therapy/Usage Dates: MIDAZOLAM AND HYDROMORPHONE, MFR UNKNOWN.
• Patient Sex: Unknown