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	04/05/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was stated that patient¿s cvc red lumen started backing up blood and started leaking at in the stopcock plastic and from the hub between the stopcock and the extension.Connections were checked and were tight prior to leaking episode as well as during the leakage.There was also air in the line between the line extension and the cap at the cvc hub.The tubing is changed.There was no delay.There was a patient involvement and no patient harm.
Additional Manufacturer Narrative
No lot number was provided; therefore, a device history record (dhr) review could not be conducted.No product was returned; therefore, no visual and functional tests were performed, the reported complaint could not be confirmed, and the root cause could not be determined.If the product is returned, the manufacturer will reopen this complaint for further investigation.

• 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 ; 6000 nathan ln n; minneapolis, MN 55442 ; 2247062300
• MDR Report Key: 25114220
• Report Number: 1526863-2026-00105
• Device Sequence Number: 18704513
• Product Code: FMG
• UDI-Device Identifier: 10351688507648
• UDI-Public: (01)10351688507648
• Combination Product (Y/N): N
• 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: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 05/07/2026

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: 04/14/2026
• Initial Report FDA Received Date: 05/07/2026
• 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): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Age: 15 MO
• Patient Sex: Male