MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. 34" EXT SET W/CLAMP, LUER LOCK; STOPCOCK, I.V. SET

Catalog Number	B1549
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/15/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device is not available for evaluation.A supplemental mdr will be submitted if any updates become available.D4: only di provided as lot number is unknown.
Event or Problem Description
The event involved a 34" ext set w/clamp, luer lock that when medical personnel came onto shift propofol infusion was observed leaking from the syringe.Patient was very difficult to sedate.The volume delivered to the patient was uncertain due to leakage.Tubing and line were replaced.There was patient involvement, but no harm.

• Brand Name: 34" EXT SET W/CLAMP, 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: 25462912
• Report Number: 9617594-2026-00578
• Device Sequence Number: 13313194
• Product Code: FMG
• UDI-Device Identifier: 00887709002555
• UDI-Public: 00887709002555
• 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,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/09/2026

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: B1549
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/21/2026
• Supplement Date Received by Manufacturer: 06/22/2026
• Initial Report FDA Received Date: 06/10/2026
• Supplement Report FDA Received Date: 07/09/2026
• 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: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown