MAUDE Adverse Event Report: ICU MEDICAL HEALTHCARE MANUFACTURING S.A. DE C.V. NRFIT CADD 100ML EPID CASSETTES; SET, IV, FLUID TRANSFER

Catalog Number	21-7600-24
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/01/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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 information becomes available.B3 - date of event: since the exact event date was unknown, it was updated as first day of the month of awareness (mar-2026).
Event or Problem Description
It was reported that there was liquid leakage from the connection part of the syringe during priming.There was no patient involvement.
Additional Manufacturer Narrative
D3 - postal code, h3, h6: updated.The suspected product was returned for evaluation.Visual inspection was performed and was confirmed that there were no anomalies noted.The lot history review confirmed that there were no previous conformities noted.The tube luer bond junction of the cassette was leak tested using hydrostatic pressure pump and a leak was confirmed.The luer tube bond of the leaking sets was separated and the tube and bond pocket was inspected.A solvent channel was observed on the tube.The allegation made by the complainant was confirmed.The probable root cause of the event was due to leakage at luer tube bond.

• Brand Name: NRFIT CADD 100ML EPID CASSETTES
• Common Device Name: SET, IV, FLUID TRANSFER
• 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: 25016527
• Report Number: 3012307300-2026-04278
• Device Sequence Number: 10303090
• Product Code: LHI
• UDI-Device Identifier: 10610586044007
• UDI-Public: (01)10610586044007(17)270106(10)6082332
• 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,Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/25/2026

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 Catalogue Number: 21-7600-24
• Device Lot Number: 6082332
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 04/23/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/06/2026
• Supplement Date Received by Manufacturer: 06/05/2026
• Initial Report FDA Received Date: 04/28/2026
• Supplement Report FDA Received Date: 06/25/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/16/2025
• 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