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

Catalog Number	21-7094-24
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/03/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that there was a drug leak from the 0.2-micron filter infusion set.There was a delay in therapy and no injury, and no medical intervention needed.The outflow channel was replaced.
Additional Manufacturer Narrative
E1 - initial reporter phone: (b)(6).Investigation including root cause analysis is in progress.A supplemental mdr will be filed as necessary in accordance with 21 cfr 803.56 when additional reportable information becomes available.
Additional Manufacturer Narrative
D3: mfg establishment name updated.H3: the device was received for evaluation.The lot history was reviewed, and no nonconformities were identified that may have contributed to the reported complaint.The used sample was leak tested at 45 psi as per manufacturing procedure using a hydrostatic pressure pump.A leak was observed from the filter air outlet.The complaint of leakage was confirmed, and the probable cause was due to the filter losing its hydrophobic properties.No further action was taken.

• Brand Name: CADD ADMINISTRATION SET
• 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: 21945683
• Report Number: 3012307300-2025-05160
• Device Sequence Number: 8836634
• Product Code: FPA
• UDI-Device Identifier: 10610586025266
• UDI-Public: (01)10610586025266(17)260727(10)4170239
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• PMA/510(K) Number: K933390
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Pharmacist
• Type of Report: Initial,Followup
• Report Date (Section B): 06/24/2025

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 Expiration Date: 07/27/2026
• Device Catalogue Number: 21-7094-24
• Device Lot Number: 4170239
• 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: 04/07/2025
• Supplement Date Received by Manufacturer: 06/05/2025
• Initial Report FDA Received Date: 05/01/2025
• Supplement Report FDA Received Date: 06/24/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/17/2021
• 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