MAUDE Adverse Event Report: ICU Medical, Inc. Small Body Stopcocks; Stopcock, i.V. Set

Catalog Number	MX5311L
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/01/2026
Type of Reportable Event	Malfunction

• Brand Name: Small Body Stopcocks
• Common Device Name: Stopcock, i.V. Set
• Manufacturer (Section D): ICU Medical, Inc.; 6250 shier rings road; dublin OH 43016
• Manufacturer Contact: reed covert ; 951 calle amanecer; san clemente, CA 92673 ; +1(224)706-2300
• MDR Report Key: 50949831
• Report Number: 1526863-2026-00174
• Device Sequence Number: 9534741
• Product Code: FMG
• UDI-Device Identifier: 10351688506795
• Combination Product (Y/N): N
• Initial Reporter State: NA
• 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): 09/30/2026

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: MX5311L
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/08/2026
• Initial Report FDA Received Date: 09/30/2026
• 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 Sex: Unknown