MAUDE Adverse Event Report: ICU MEDICAL 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	12/01/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A supplemental mdr will be filed as necessary in accordance with 21 cfr 803.56 when additional reportable information becomes available.
Event or Problem Description
It was reported there was a liquid leakage from the side of the tube when injecting the solution.This during priming.
Additional Manufacturer Narrative
D4 - expiration date: corrected.D4 - primary udi number: corrected.H4 - device mfr date: updated.H3 and h6 codes - updated.One used device was returned for investigation.The device was visually inspected and there was no damage or anomalies were observed.During the functional testing, a leak was observed between the tubing and female luer of the cassette.The luer tube bond was separated and the tube and bond pocket was observed.The complaint of leakage can be confirmed due to the failure mode observed of leakage at luer tube bond however, root cause analysis is being addressed under a formal capa investigation.A device history record (dhr) review was conducted which indicated all inspections were completed and no issues were noted during manufacture.

• Brand Name: NRFIT CADD 100ML EPID CASSETTES
• Common Device Name: SET, IV, FLUID TRANSFER
• Manufacturer (Section D): ICU MEDICAL MANUFACTURING S.A. DE C.V.; ave calidad no. 4, parque; tijuana ; MX
• Manufacturer Contact: reed covert ; 6000 nathan ln n; minneapolis, MN 55442 ; 2247062300
• MDR Report Key: 24368532
• Report Number: 3012307300-2026-01367
• Device Sequence Number: 5381118
• Product Code: LHI
• UDI-Device Identifier: 10610586044007
• UDI-Public: (01)10610586044007(17)300212(10)6092866
• 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: Pharmacist
• Type of Report: Initial,Followup
• Report Date (Section B): 04/20/2026

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: 6092866
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 01/29/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/28/2026
• Supplement Date Received by Manufacturer: 03/27/2026
• Initial Report FDA Received Date: 02/17/2026
• Supplement Report FDA Received Date: 04/20/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/20/2025
• 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