MAUDE Adverse Event Report: ICU Medical, Inc. Medex Hi-Flo 4-Way Stopcock; Stopcock, I.V. Set

Catalog Number	MX9341L
Medical Device Problem Codes	Break (1069); Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/08/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that, upon evaluation of the additionally received medex stopcocks, cracking was observed along the a-port shafts of the returned device.The reported defect was confirmed.There was patient involvement and moderate patient harm.
Additional Manufacturer Narrative
Initial reporter phone number with extension (b)(6).One sample was returned for evaluation.The lot history was reviewed, and no nonconformities were identified that could have contributed to the reported complaint.Visual inspection and functional testing were performed on the returned device.The device exhibited cracking along the a-port shaft, confirming the reported defect.The location and nature of the cracking are consistent with stresses that may result from excessive applied torque, such as over-tightening during connection.Based on the evaluation findings, the observed breakage is consistent with loading conditions exceeding those expected during normal use.

• Brand Name: Medex Hi-Flo 4-Way Stopcock
• 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: 50883606
• Report Number: 1526863-2026-00168
• Device Sequence Number: 10754560
• Product Code: FMG
• UDI-Device Identifier: 10351688504173
• 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): 09/24/2026

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: Other
• Device Catalogue Number: MX9341L
• Device Lot Number: 6146467
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 07/09/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/26/2026
• Initial Report FDA Received Date: 09/24/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/07/2025
• 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: Hydromorphone.; Propofol.
• Patient Age: 29 YR
• Patient Sex: Female