MAUDE Adverse Event Report: ICU MEDICAL HEALTHCARE MANUFACTURING S.A. DE C.V. NRFIT CONNECTOR, SET; SET, I.V. FLUID TRANSFER

Catalog Number	21-7608-24
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
Event or Problem Description
It was reported that liquid leakage occurred near the cassette-side connection point.The event occurred during the patient use.There was no adverse event.
Additional Manufacturer Narrative
B3: unknown; no information has been provided to date.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.
Additional Manufacturer Narrative
D3.Mfr establishment name: correction.H3 and h6.Codes: updated.Device evaluation: received one (1) used nrfit administration set attached to nrfit cassette.As received no damage or anomalies were observed.The sample was leak tested using a hydrostatic pressure pump.No leakage was observed.The complaint of leakage cannot be replicated or confirmed.A device history record review could not be conducted as the lot number was unknown.

• Brand Name: NRFIT CONNECTOR, SET
• Common Device Name: SET, I.V. 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: 24201601
• Report Number: 3012307300-2026-00633
• Device Sequence Number: 5557997
• Product Code: LHI
• UDI-Device Identifier: 10610586043994
• UDI-Public: (01)10610586043994
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K162219
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/24/2026

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: Lay User/Patient
• Device Catalogue Number: 21-7608-24
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 01/20/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/07/2026
• Supplement Date Received by Manufacturer: 03/18/2026
• Initial Report FDA Received Date: 01/28/2026
• Supplement Report FDA Received Date: 03/25/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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