MAUDE Adverse Event Report: ICU Medical Slovakia s.r.o 16 cm (6.5") Smallbore Ext Set w/MicroClave® Clear, 0.2 Micron Positive Filter,; Stopcock, I.V. Set

Catalog Number	011-MC33038
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/01/2026
Type of Reportable Event	Malfunction

• Brand Name: 16 cm (6.5") Smallbore Ext Set w/MicroClave® Clear, 0.2 Micron Positive Filter,
• Common Device Name: Stopcock, I.V. Set
• Manufacturer (Section D): ICU Medical Slovakia s.r.o; albert einsteinweg 11; roemond NA 6045 GX; NL 6045 GX
• Manufacturer Contact: reed covert ; 951 calle amanecer; san clemente, CA 92673 ; +1(224)706-2300
• MDR Report Key: 50924551
• Report Number: 3009225128-2026-00002
• Device Sequence Number: 5777229
• Product Code: FMG
• UDI-Device Identifier: 00840619053727
• UDI-Public: (01)00840619053727
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K964435
• 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: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 09/28/2026

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: 011-MC33038
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/09/2026
• Initial Report FDA Received Date: 09/28/2026
• 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 Age: 6 YR
• Patient Sex: Male