MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. 3-WAY HIGH FLOW STOPCOCK W/ROTATING LUER; STOPCOCK, I.V. SET

Catalog Number	B4020
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/08/2026
Type of Reportable Event	Malfunction
Event or Problem Description
The event involved a 3-way high flow stopcock w/rotating luer where the customer reported that unspecified sedation medication was being infused when they noticed blood backing up in iv catheter and leaking out the stopcock.The customer flushed the line and noticed flush was coming out of a side slit on the stopcock; medication was seeping out of side slit.The customer stated that the defective stopcock caused patient to be underdosed, and minimal loss of blood to the patient with the break in system.There was patient involvement but harm was not reported as a consequence of this event.
Additional Manufacturer Narrative
The device is not available for evaluation, but lot history review should be performed.
Additional Manufacturer Narrative
The reported complaint of back flow 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.The lot history was reviewed; no nonconformities were identified that may have contributed to the reported complaint.

• Brand Name: 3-WAY HIGH FLOW STOPCOCK W/ROTATING LUER
• 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: 24173504
• Report Number: 9617594-2026-00033
• Device Sequence Number: 13256788
• Product Code: FMG
• UDI-Device Identifier: 00887709008717
• UDI-Public: (01)00887709008717(17)300901(10)14568165
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: K080077
• 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): 03/10/2026

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: B4020
• Device Lot Number: 14568165
• 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: 01/12/2026
• Supplement Date Received by Manufacturer: 01/20/2026
• Initial Report FDA Received Date: 01/24/2026
• Supplement Report FDA Received Date: 03/10/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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
• Patient Sex: Unknown