MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. 72" (183CM) APPX 1.4ML, SMALLBORE EXT SET W/ ANTI-SIPHON VALVE, CLAMP, LUER LOC; STOPCOCK, I.V. SET

Catalog Number	B2038
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/25/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device return is unknown however a device history review should be performed, and a supplemental report will be submitted.(b)(6).
Event or Problem Description
An event involved a 72" (183cm) appx 1.4ml, smallbore ext set w, anti-siphon valve, clamp, luer lock where it was reported that during infusion the tubing starts to leak mid case used for propofol on tiva (total intravenous anesthesia pumps) pumps.There was patient involvement, and unknown harm reported.

• Brand Name: 72" (183CM) APPX 1.4ML, SMALLBORE EXT SET W/ ANTI-SIPHON VALVE, CLAMP, LUER LOC
• 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: 24739210
• Report Number: 9617594-2026-00325
• Device Sequence Number: 10265480
• Product Code: FMG
• UDI-Device Identifier: 00887709002999
• UDI-Public: (01)00887709002999(17)300901(10)14565772
• 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,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 03/31/2026

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: B2038
• Device Lot Number: 14565772
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/25/2026
• Initial Report FDA Received Date: 03/31/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/06/2025
• 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: PROPOFOL, UNK MFR
• Patient Sex: Unknown