MAUDE Adverse Event Report: ICU MEDICAL HEALTHCARE MANUFACTURING S.A. DE C.V CADD CLEO INFUSION SET; SET, ADMINISTRATION, INTRAVASCULAR

Catalog Number	21-7221-24
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/20/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation including root cause analysis is in progress.A supplemental mdr will be filled as necessary in accordance with 21 cfr 803.56 when additional reportable information becomes available.
Event or Problem Description
It was reported that leakage occurred during use at the abdomen insertion site.The leakage was reported on the cannula side at the clip (tubing) connection, occurring after a few minutes to hours following placement.A total of three devices were involved, with 2 different lot numbers.There was no patient harm.

• Brand Name: CADD CLEO INFUSION SET
• Common Device Name: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): ICU MEDICAL HEALTHCARE MANUFACTURING S.A. DE C.V; ave calidad no. 4, parque; tijuana ; MX
• Manufacturer Contact: reed covert ; 6000 nathan lane north; minneapolis, MN 55442 ; 2247062300
• MDR Report Key: 24897219
• Report Number: 3012307300-2026-03844
• Device Sequence Number: 9844985
• Product Code: FPA
• UDI-Device Identifier: 30610586028346
• UDI-Public: (01)30610586028346(17)300305(10)6101912
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K042172
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 04/16/2026

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: Lay User/Patient
• Device Catalogue Number: 21-7221-24
• Device Lot Number: 6101912
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/26/2026
• Initial Report FDA Received Date: 04/16/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/27/2025
• 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