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

Catalog Number	21-7605-24
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/01/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
B3: year and month of event has been provided; day is unknown.One used device was returned for investigation.The devices were visually inspected.There were no anomalies noted upon visual inspection.During functional testing, a leak was observed at the tube luer junction.The complaint of leakage can be confirmed due to the failure mode observed of leakage at luer tube bond.The probable cause is due to insufficient solvent coverage application during assembly.The device history file was reviewed.There were no discrepancies noted relevant to the indicated failure mode.
Event or Problem Description
It was reported that there was liquid leakage from the connection part between the tube and the connector during priming.There was no patient involvement.

• Brand Name: CADD EXTENSION SETS NRFIT
• Common Device Name: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): ICU MEDICAL HEALTHCARE MANUFACTURING S.A. DE C.V.; ave calidad no. 4, parque; tijuana 22425 ; MX 22425
• Manufacturer Contact: reed covert ; 6000 nathan lane north; minneapolis, MN 55442 ; 2247062300
• MDR Report Key: 24259099
• Report Number: 3012307300-2026-00886
• Device Sequence Number: 15853031
• Product Code: LHI
• UDI-Device Identifier: 10610586044113
• UDI-Public: (01)10610586044113(17)270304(10)6102003
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K162219
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 02/04/2026

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: Other
• Device Catalogue Number: 21-7605-24
• Device Lot Number: 6102003
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/11/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/18/2025
• Initial Report FDA Received Date: 02/04/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/21/2025
• 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