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

Model Number	7624
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Skin Infection (4544)
Date of Event	05/01/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported since cases of infection at the epidural catheter insertion site occur approximately once a month, the operator would like to confirm whether the product we are using together is properly sterilized.The event occurred during use and patient was harmed due to having an infection.
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.
Additional Manufacturer Narrative
One new device sample was returned for evaluation, along with photos of the product.Visual inspection did not identify any defects of the device.According to the reports of sterilization, there were no issues during the sterilization process of this product identified through product history review.The reported issue was no table to be confirmed.A lot history review was performed and no nonconformances were identified.

• Brand Name: NRFIT ADMINISTRATION SET
• Common Device Name: SET, I.V. FLUID TRANSFER
• 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: 22162589
• Report Number: 3012307300-2025-06741
• Device Sequence Number: 8841905
• Product Code: LHI
• UDI-Device Identifier: 10610586044748
• UDI-Public: (01)10610586044748(17)260729(10)6026769
• 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): 09/04/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 07/29/2026
• Device Model Number: 7624
• Device Catalogue Number: 21-7624-24
• Device Lot Number: 6026769
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 05/22/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/13/2025
• Supplement Date Received by Manufacturer: 08/18/2025
• Initial Report FDA Received Date: 06/07/2025
• Supplement Report FDA Received Date: 09/04/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/09/2024
• 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