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	03/23/2026
Type of Reportable Event	Malfunction
Event or Problem Description
The event involved a 72" (183cm) appx 1.4ml, smallbore ext set w, anti-siphon valve, clamp, luer lock and it was reported that there is a leak in the tubing and patient.The event occurred during infusion of propofol.There was patient involvement, and unknown harm.
Additional Manufacturer Narrative
The device has been requested for evaluation; however, it has not yet been received.(b)(6).

• 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: 24738758
• Report Number: 9617594-2026-00320
• Device Sequence Number: 13367379
• 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: Physician
• 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