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 Codes	Crack (1135); Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/29/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that while using the 4-way stopcock the leur lock connector was cracked and resulted in the patient not receiving the appropriate amount of infusion medication.It was stated that patient was receiving medication for sedation and it was leaked.So, the patient began to wake up.Patient was extremely sick.The nurse didn¿t realize the product had cracked and that the med was leaking into the bed, it took several minutes before the nurse realized what was happening.And then there was a delay with care while the nurse replaced the product.The patient temporarily had a decrease in the level of sedation thus requiring higher doses of medications being infused the nurse as well had to quickly find alternative access for the infusions while the replacement product was being prepared.There were patient involvement and harm.
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.

• 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 ; +1(224)706-2300
• MDR Report Key: 50213824
• Report Number: 1526863-2026-00161
• Device Sequence Number: 18620768
• Product Code: FMG
• UDI-Device Identifier: 10351688504173
• UDI-Public: (01)10351688504173(17)280904(10)6146454
• Combination Product (Y/N): N
• Initial Reporter State: NA
• Initial Reporter Country: CA
• 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: Foreign,User Facility
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 08/11/2026

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: Other
• Device Catalogue Number: MX9341L
• Device Lot Number: 6146454
• 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: 07/14/2026
• Initial Report FDA Received Date: 08/11/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/17/2025
• 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