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	02/01/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device has been returned to manufacturer.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: unknown.
Event or Problem Description
It was reported that the cassette is leaking at the connection of the tubing and the yellow plastic connector during filling, in the production facilities.There was no patient involvement, and no human harm or adverse event.
Additional Manufacturer Narrative
Two pictures were returned showing a leak from the nrfit luer and tubing junction.Functional and visual tests were done the reported issue can be duplicated.The lot history was reviewed, no relevant nonconformities were identified that may have contributed to the reported complaint.

• 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.; avenida calidad no.4; parqueindustrial internacional; tijuana, b.c. c.p NM 22425
• Manufacturer Contact: reed covert ; 6000 nathan lane n; minneapolis, MN 55442 ; 2247062300
• MDR Report Key: 24389405
• Report Number: 3012307300-2026-01475
• Device Sequence Number: 10567773
• Product Code: LHI
• UDI-Device Identifier: 10610586044007
• UDI-Public: (01)10610586044007(17)260305(10)4468680
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• 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: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/22/2026

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 Expiration Date: 03/05/2026
• Device Catalogue Number: 21-7600-24
• Device Lot Number: 4468680
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/11/2026
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/02/2026
• Supplement Date Received by Manufacturer: 03/31/2026
• Initial Report FDA Received Date: 02/19/2026
• Supplement Report FDA Received Date: 04/22/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/27/2024
• 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