MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. 7.5" (19 CM) APPX 0.54 ML, SMALLBORE TRIFUSE EXT SET W/3 MICROCLAVE¿ CLEAR, 3 CL; STOPCOCK, I.V. SET

Catalog Number	MC330577
Medical Device Problem Codes	Crack (1135); No Flow (2991)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/03/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device is expected to be returned for evaluation; however, it has not yet been received.
Event or Problem Description
The event involved a smallbore trifuse ext set w/3 microclave clear clamps where the customer reported that the trifuse was breaking off at the connection site to the patient, and the central line had clotted off.There was no reported patient harm.
Additional Manufacturer Narrative
D9 - date returned to mfr: 2/26/2026.An email was received regarding smallbore trifuse ext set w/3 microclave clear clamps with item number mc330577 and lot number 14596550.It was reported that trifuse were breaking off at the connection site to the patient and the central line had clotted off.The event occurred while use on a patient with medications infusing.There was no patient harm but a delay in therapy.The lot history was reviewed, and no nonconformities were identified that may have contributed to the reported complaint.

• Brand Name: 7.5" (19 CM) APPX 0.54 ML, SMALLBORE TRIFUSE EXT SET W/3 MICROCLAVE¿ CLEAR, 3 CL
• 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.
• Manufacturer Contact: reed covert ; 600 n. field dr.; lake forest, IL 60045 ; 2247062300
• MDR Report Key: 24489464
• Report Number: 9617594-2026-00212
• Device Sequence Number: 18808053
• Product Code: FMG
• UDI-Device Identifier: 00887709095441
• UDI-Public: (01)00887709095441(17)300901(10)14596550
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/17/2026

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: MC330577
• Device Lot Number: 14596550
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/17/2026
• Supplement Date Received by Manufacturer: 04/07/2026
• Initial Report FDA Received Date: 03/02/2026
• Supplement Report FDA Received Date: 04/17/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/22/2025
• 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: CALCIUM CHLORIDE,, MFR UNK.; EPINEPHRINE, MFR UNK.
• Patient Sex: Unknown