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	07/24/2025
Type of Reportable Event	Malfunction
Event or Problem Description
Event occurred regarding a 72" (183cm) smallbore ext set w/ anti-siphon valve, clamp, luer lock where the report stated that "the tubing started leaking at the joint in hub and not at the connection to the iv tubing but within the hub itself.The event was discovered in the operating room when the patient started to wake up during a procedure because the medication was going to the floor instead of the patient.".There was patient involvement but no adverse event reported.
Additional Manufacturer Narrative
Additional reporter: (b)(6).Investigation summary: the reported complaint of a leak could not be confirmed.Without the return of the sample or a photo/video a comprehensive review cannot be performed and a probable cause cannot be determined.No lot received for a device history review.

• 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: 22903764
• Report Number: 9617594-2025-01757
• Device Sequence Number: 8018124
• Product Code: FMG
• UDI-Device Identifier: 00887709002999
• UDI-Public: 00887709002999
• 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,Company Representative,Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 08/27/2025

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: B2038
• Device Lot Number: UNKNOWN
• 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: 07/31/2025
• Initial Report FDA Received Date: 08/27/2025
• 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
• Concomitant Medical Products and Therapy/Usage Dates: PROPOFOL (MFR UNKNOWN)
• Patient Sex: Unknown