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	04/01/2026
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: the exact date of the incident is unknown, so it has been recorded as the first day of the month of awareness.
Event or Problem Description
An event involving a nrfit cadd 100ml epid cassettes reported that in which, upon opening the cassette, fluid leakage was observed from the yellow connector attached to the syringe during drug filling.There was no patient involvement and no harm/adverse event reported.
Additional Manufacturer Narrative
D3 - postal code, d4 - primary udi number: corrected d3 - zip code: must be blank.H3, h6: updated.The suspect product was returned for evaluation.Visual inspection confirmed that there were no anomalies found.The lot history review was performed, and it was confirmed that there were no previous conformities noted.Leak test was performed and it was found that there was a leak observed at the tube luer junction of the cassette during the ramp up.The bond was separated, inspected and was found that a solvent channel was present on the tube.The allegation made by the complainant was confirmed.However, the probable root cause of the event was unable to be determined.

• 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: 25241784
• Report Number: 3012307300-2026-05257
• Device Sequence Number: 9597177
• Product Code: LHI
• UDI-Device Identifier: 10610586044007
• UDI-Public: (01)10610586044007(17)270901(10)6147697
• 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
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/16/2026

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: Health Professional
• Device Catalogue Number: 21-7600-24
• Device Lot Number: 6147697
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 05/01/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/30/2026
• Supplement Date Received by Manufacturer: 06/30/2026
• Initial Report FDA Received Date: 05/21/2026
• Supplement Report FDA Received Date: 07/16/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/10/2025
• 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