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	Unspecified Infection (1930)
Date of Event	02/02/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
No information has been provided to date.Investigation including root cause analysis is in progress.A supplemental mdr will be filled as necessary in accordance with 21 cfr 803.56 when additional reportable information becomes available.
Event or Problem Description
It was stated that cracking and leaking occurred during use.The procedure stopcock is being used for when the issues occurred was during infusion.The fault occurred every time the device was used with a patient, and it resulted in harm, specifically clabsi (central line-associated bloodstream infection).There were patient involvement and patient harm.
Additional Manufacturer Narrative
No product or supporting images were provided for this investigation.As a result, the complaint could not be confirmed.Manufacturing records, historical complaint data, and known failure modes were assessed, and no evidence was identified linking this concern to a manufacturing-related issue.A device history review was performed for lot number, and no non-conformances were generated during the manufacturing period.

• 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.; 6000 nathan lane north; minneapolis MN 55442
• Manufacturer Contact: reed covert ; 6250 shier rings road; dublin, OH 43016 ; 2247062300
• MDR Report Key: 24629535
• Report Number: 1526863-2026-00068
• Device Sequence Number: 9201461
• 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: User Facility
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 05/19/2026

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: 03/18/2026
• Supplement Report FDA Received Date: 05/19/2026
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown