MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. 4 GANG 4-WAY STOPCOCK W/BASEPLATE; STOPCOCK, I.V. SET

Catalog Number	B4078
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/11/2026
Type of Reportable Event	Malfunction
Event or Problem Description
The event involved a 4 gang, 4-way, stopcock w/baseplate where the customer reported that the product was leaking between the first and second stopcock; both were infusing vasoactive of milrinone and epinephrine.Patient on significant vasoactive support, high concern due to instability of patient and requiring line change.No harm due to train (stopcock) itself, but because the patient was extremely unstable, need to change line was of high concern due to leaking.Any small change equals patient decompensates, so having to change line early due to leaking was concerning.There was patient involvement, but harm was not reported as a consequence of this event.
Additional Manufacturer Narrative
The device is expected to be returned for evaluation; however, it has not yet been received.
Additional Manufacturer Narrative
The complaint could not be confirmed by investigation.No product samples, pictures, or videos were received for investigation.Without the return of the used sample a comprehensive failure investigation cannot be performed, and a cause cannot be determined.The device history report (dhr) was reviewed, and no nonconformities were found that would have led to the reported complaint.

• Brand Name: 4 GANG 4-WAY STOPCOCK W/BASEPLATE
• 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: 24497837
• Report Number: 9617594-2026-00218
• Device Sequence Number: 10115723
• Product Code: FMG
• UDI-Device Identifier: 00887709008847
• UDI-Public: (01)00887709008847(17)190513(10)4089345
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• 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: Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/24/2026

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 05/01/2024
• Device Catalogue Number: B4078
• Device Lot Number: 4089345
• 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: 02/17/2026
• Supplement Date Received by Manufacturer: 04/13/2026
• Initial Report FDA Received Date: 03/03/2026
• Supplement Report FDA Received Date: 04/24/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/13/2019
• 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: MILRINONE AND EPINEPHRINE, MFR UNK.
• Patient Sex: Unknown