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

Catalog Number	MX9341L
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
Additional Manufacturer Narrative
Device has not been returned to manufacturer.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 cracking and leaking occurred during infusion.There was patient involvement, and patient harm.

• Brand Name: MEDEX HI-FLO 4-WAY STOPCOCK W/SWIVEL MALE LUER LOCK
• 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 ; 2247062300
• MDR Report Key: 24649141
• Report Number: 1526863-2026-00071
• Device Sequence Number: 13279373
• Product Code: FMG
• UDI-Device Identifier: 10351688504173
• UDI-Public: (01)10351688504173(17)280724(10)6126896
• 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: Health Professional,User Facility
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 05/18/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: MX9341L
• Device Lot Number: 6126896
• 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: 02/25/2026
• Supplement Date Received by Manufacturer: 04/28/2026
• Initial Report FDA Received Date: 03/20/2026
• Supplement Report FDA Received Date: 05/18/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/12/2025
• 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: UNSPECIFIED STANDARD INFUSION, UNK MFR
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown