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	Obstruction of Flow (2423)
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: 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
It was reported that it was blocked and the liquid medicine could not pass through occurred during priming.There was no patient involvement and no patient harm/adverse event reported.
Additional Manufacturer Narrative
D4: updated lot, expiration date and udi details.H3: updated device manufacture date.H6: codes were updated.One used device was returned for evaluation, and the lot history was reviewed; no nonconformities were identified that may have contributed to the reported complaint.During visual inspection, no damages or anomalies were observed.Functional test was performed and confirmed priming was unsuccessful as an occlusion was observed proximal to the inline filter.Upon closer inspection, a solvent membrane was observed within the tubing lumen.The complaint of an occlusion can be confirmed.The probable cause is due to a solvent application error during manufacturing.

• 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: 24630328
• Report Number: 3012307300-2026-02644
• Device Sequence Number: 8688365
• Product Code: LHI
• UDI-Device Identifier: 10610586043994
• UDI-Public: (01)10610586043994(17)270207(10)6093187
• 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): 05/26/2026

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: 21-7608-24
• Device Lot Number: 6093187
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 03/16/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/03/2026
• Supplement Date Received by Manufacturer: 05/05/2026
• Initial Report FDA Received Date: 03/18/2026
• Supplement Report FDA Received Date: 05/26/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/04/2025
• 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