MAUDE Adverse Event Report: ICU Medical Healthcare Manufacturing S.A. de C.V. Medex 3-Way Stopcock Extension Set; Tubing, fluid delivery

Catalog Number	MX43660
Medical Device Problem Code	Separation Problem (4043)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/01/2026
Type of Reportable Event	Malfunction

• Brand Name: Medex 3-Way Stopcock Extension Set
• Common Device Name: Tubing, fluid delivery
• Manufacturer (Section D): ICU Medical Healthcare Manufacturing S.A. de C.V.; carretera miguel alemán km21.7; parque industrial monterrey; apodaca nuevo leon NA 66603 ; MX 66603
• Manufacturer Contact: reed covert ; 6250 shier rings road; dublin, OH 43016 ; +1(224)706-2300
• MDR Report Key: 50859789
• Report Number: 9616567-2026-00034
• Device Sequence Number: 18530313
• Product Code: FPK
• UDI-Device Identifier: 10351688507563
• UDI-Public: (01)10351688507563
• Combination Product (Y/N): N
• Initial Reporter State: WA
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 09/22/2026

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: MX43660
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 09/02/2026
• 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: 09/22/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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 Sex: Unknown