MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. 14"(36CM)APPX3.0ML, TRIFUSE EXT SET W/3 MICROCLAVE CLEAR¿,3 BCV,4-WAY NANOCLAVE¿; STOPCOCK, I.V. SET

Catalog Number	AC235
Medical Device Problem Codes	Break (1069); Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/01/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
B3 - date of event - the date of event is unknown, and 01 jan 2025 has been used as a placeholder.D4 and h4 the lot#, expiration date, and manufacture date are unknown.Investigation summary two (2) used list # ac235 and two (2) used unknown, bifuse ext set connected in one of them were returned for evaluation.As received, one of the male luer was observed to be separated and missing from the set, the tube was visually inspected through uv light and not enough presence of solvent was confirmed.The outer diameter of the tube was measured finding within specification.The sample with male luer was pulled tested and passed the product specification.No additional damage or anomalies were confirmed.A device history record lot# review could not be conducted because no lot number(s) was/were identified.Complaint of disconnection / loose connection can be confirmed.The probable cause is due to insufficient solvent applied during manual process assembly at ensenada.
Event or Problem Description
A complaint was received regarding a 14"(36cm) appx 3.0ml, trifuse ext set w/3 microclave clear¿,3 bcv,4-way nanoclave¿ stopcock(red ring) that experienced disconnection during use.The report stated "rn was assessing the patient and noticed that the tubing had disconnected from the purple lumen.The trifuse had broken at the area closed to the patient connection.The male connection had broken off from the rest of the trifuse and was still connected to the patient.The patient mother reported that this has happened a few other times".There was patient involvement and no injuries or adverse event.

• Brand Name: 14"(36CM)APPX3.0ML, TRIFUSE EXT SET W/3 MICROCLAVE CLEAR¿,3 BCV,4-WAY NANOCLAVE¿
• 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: 22538532
• Report Number: 9617594-2025-01493
• Device Sequence Number: 15309951
• Product Code: FMG
• UDI-Device Identifier: 00887709122062
• UDI-Public: 00887709122062
• Combination Product (Y/N): N
• Initial Reporter State: TN
• 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
• Report Date (Section B): 07/17/2025

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: AC235
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/24/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/20/2025
• Initial 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: UNSPECIFIED BIFUSE EXT SET, MFR UNKNOWN
• Patient Sex: Unknown