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	02/01/2026
Type of Reportable Event	Malfunction
Event or Problem Description
An event occurred on an unspecified date involving a 4 gang 4-way stopcock w/baseplate; reported that within 1 hour after the manifold/product was placed on the patient, the rn noted leaking from the device.This was infusing critical medications like epinephrine and milrinone.The patient remained stable doing switch to new tubing/manifold.There was patient involvement, and no harm/adverse event reported.
Additional Manufacturer Narrative
The device has been received for evaluation; however, investigation is not yet complete.Additional contact information (b)(6).
Event or Problem Description
Void justification: this record was voided since this is a duplicate of existing record under cn-(b)(4).
Additional Manufacturer Narrative
Void justification: this record was voided since this is a duplicate of existing record under cn-(b)(4).

• 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: 24543235
• Report Number: 9617594-2026-00240
• Device Sequence Number: 17536097
• Product Code: FMG
• UDI-Device Identifier: 00887709008847
• UDI-Public: (01)00887709008847(17)301001(10)14640579
• 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: User Facility,Company Representative,Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/17/2026

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: B4078
• Device Lot Number: 14640579
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/25/2026
• Supplement Date Received by Manufacturer: 03/17/2026
• Initial Report FDA Received Date: 03/09/2026
• Supplement Report FDA Received Date: 03/17/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/10/2025
• 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: EPINEPHRINE, UNK MFR.; MILRINONE, UNK MFR.
• Patient Sex: Unknown