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

Model Number	7094
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/08/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
E3: additional reporter phone number (b)(6).This file was originally incorrectly filed under registration number mrn 9617604-2025-00214-00.The date of that submission was (b)(6)2025.A supplemental mdr will be filed as necessary in accordance with 21 cfr 803.56 when additional reportable information becomes available.
Event or Problem Description
It was reported that there was a drug leak from the 0.2 micron filter infusion set.The issue occurred during infusion.There was a therapy delay.There was patient involvement.There was no injury, and no medical intervention needed.
Additional Manufacturer Narrative
One new sample was received.The new sample was leak tested at 45 psi as per manufacturing procedure using a hydrostatic pressure pump.No leaks were observed.The complaint of leakage cannot be confirmed nor replicated.Without the return of the used sample, a comprehensive failure investigation cannot be performed, and a cause cannot be determined.The lot history was reviewed; no nonconformities were identified that may have contributed to the reported complaint.

• Brand Name: CADD ADMINISTRATION SETS
• Common Device Name: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): ICU MEDICAL, INC.; ave calidad no. 4, parque; tijuana ; MX
• Manufacturer Contact: reed covert ; 6000 nathan lane north; minneapolis, MN 55442 ; 2247062300
• MDR Report Key: 22308617
• Report Number: 3012307300-2025-07494
• Device Sequence Number: 20853324
• Product Code: FPA
• UDI-Device Identifier: 10610586025266
• UDI-Public: (01)10610586025266(17)290304(10)6053834
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• PMA/510(K) Number: K933390
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility
• Initial Reporter Occupation: Pharmacist
• Type of Report: Initial,Followup
• Report Date (Section B): 06/25/2025

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: 7094
• Device Catalogue Number: 21-7094-24
• Device Lot Number: 6053834
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 04/21/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/09/2025
• Supplement Date Received by Manufacturer: 06/05/2025
• Initial Report FDA Received Date: 06/23/2025
• Supplement Report FDA Received Date: 06/25/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/13/2024
• 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