MAUDE Adverse Event Report: ICU Medical, Inc. Medex 4-Way Stopcock; Stopcock I.V. Set

Catalog Number	MX2341L
Medical Device Problem Code	Air/Gas in Device (4062)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/01/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that air was observed entering the line of the ultra¿ 4-way stopcock with swivel male luer lock, despite the connections being reported as secure.There was patient involvement; however, no patient harm or adverse event was reported.
Additional Manufacturer Narrative
B3 ¿ date of event: the exact date of the event is unknown; therefore, the first day based on the icu medical awareness date was entered as the event date.Investigation including root cause analysis is in progress.A supplemental mdr will be filed as necessary in accordance with 21 cfr 803.56 when additional information becomes available.

• Brand Name: Medex 4-Way Stopcock
• Common Device Name: Stopcock I.V. Set
• Manufacturer (Section D): ICU Medical, Inc.; 6250 shier rings road; dublin OH 43016
• Manufacturer Contact: reed covert ; 6250 shier rings road; dublin, OH 43016 ; +1(224)706-2300
• MDR Report Key: 50903500
• Report Number: 1526863-2026-00170
• Device Sequence Number: 14928779
• Product Code: FMG
• UDI-Device Identifier: 10351688508324
• UDI-Public: (01)10351688508324(17)290513(10)6203385
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: Unknown
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 09/25/2026

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: Other
• Device Catalogue Number: MX2341L
• Device Lot Number: 6203385
• 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: 09/02/2026
• Initial Report FDA Received Date: 09/25/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/18/2026
• 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