MAUDE Adverse Event Report: ICU MEDICAL, INC. ICU MEDICAL; SET, ADMINISTRATION, INTRAVASCULAR

Model Number	CH2000SC-10
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	06/29/2026
Type of Reportable Event	Malfunction
Event or Problem Description
Fluid would not push through the plunger; plunger in syringe port got stuck/ would not allow fluid to pass.17 total devices: lot numbers included: 14925498- x6 syringes: 14988298.14839655- x3 syringes: 14815765, 14789286, 14813882.14739286- x2 syringes: 14529298, 14910371.

• Brand Name: ICU MEDICAL
• Common Device Name: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): ICU MEDICAL, INC.; 951 calle amanecer; san clemente CA 92673
• MDR Report Key: 25746916
• Report Number: 25746916
• Device Sequence Number: 18702871
• Product Code: FPA
• UDI-Device Identifier: 00840619042769
• UDI-Public: (01)00840619042769
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 07/01/2026
• Report Date (Section F): 07/01/2026

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 Model Number: CH2000SC-10
• Device Catalogue Number: CH2000SC-10
• Device Lot Number: MULTIPLE
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 07/08/2026
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 07/08/2026
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown
• Date Report Sent to FDA: 07/01/2026