MAUDE Adverse Event Report: ICU MEDICAL ASD, INC. MEDEX HI-FLO 4-WAY STOPCOCK W/MALE LUER LOCK; STOPCOCK, I.V. SET

Catalog Number	MX4341L
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/20/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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.
Event or Problem Description
It was reported that the patient had a double stopcock used for drawing labs from the picc line and after labs were drawn and aspirated from the closest stopcock, blood began spraying due to a hole in the stopcock.Per reporter, the nurse indicated the leak appeared to occur where the stopcock turned, before the cap, and that the cap was tight and the leak appeared to be high-pressure, likely from a small hole.No patient harm occurred or adverse event was reported.

• Brand Name: MEDEX HI-FLO 4-WAY STOPCOCK W/MALE LUER LOCK
• Common Device Name: STOPCOCK, I.V. SET
• Manufacturer (Section D): ICU MEDICAL ASD, INC.; 6250 shier rings road; dublin OH 43016
• Manufacturer Contact: reed covert ; 6250 shier rings road; dublin, OH 43016 ; 2247062300
• MDR Report Key: 24930212
• Report Number: 1526863-2026-00098
• Device Sequence Number: 10652197
• Product Code: FMG
• UDI-Device Identifier: 10351688507648
• UDI-Public: (01)10351688507648
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• 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: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/27/2026

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: MX4341L
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/30/2026
• Supplement Date Received by Manufacturer: 05/05/2026
• Initial Report FDA Received Date: 04/20/2026
• Supplement Report FDA Received Date: 05/27/2026
• 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): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown