MAUDE Adverse Event Report: SMITHS HEALTHCARE MANUFACTURING S.A. DE C.V. NRFIT ADMINISTRATION SET; ADMINISTRATIONS SETS WITH NEURAXIAL CONNECTORS

Model Number	21-7624-24
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/13/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This file was originally incorrectly filed under registration number mrn 9617604-2025-00198.The date of that submission was 19-mar-2025.One device was received for investigation.The reported issue was confirmed during functional testing when the reported leaking issue was duplicated.However, the investigation did not identify a root cause for the observed condition.The product's history records were reviewed and there were no non-conformances nor service-related issues that would have resulted in the reported complaint.Complaint information will continue to be monitored.
Event or Problem Description
It was reported that the tubing at the clip-on leaked.There was patient involvement, no patient injury was reported.

• Brand Name: NRFIT ADMINISTRATION SET
• Common Device Name: ADMINISTRATIONS SETS WITH NEURAXIAL CONNECTORS
• Manufacturer (Section D): SMITHS HEALTHCARE MANUFACTURING S.A. DE C.V.; ave calidad no. 4, parque; tijuana ; MX
• Manufacturer Contact: reed covert ; 6000 nathan lane n; minneapolis, MN 55442 ; 2247062300
• MDR Report Key: 22018315
• Report Number: 3012307300-2025-05673
• Device Sequence Number: 15823568
• Product Code: PWH
• UDI-Device Identifier: 10610586044748
• UDI-Public: (01)10610586044748(17)260417(10)6006521
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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
• Report Date (Section B): 05/14/2025

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: 04/17/2026
• Device Model Number: 21-7624-24
• Device Catalogue Number: 21-7624-24
• Device Lot Number: 6006521
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/05/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/20/2025
• Initial Report FDA Received Date: 05/14/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/07/2024
• 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