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

Catalog Number	21-7624-24
Medical Device Problem Code	Device Markings/Labelling Problem (2911)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/20/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that there was a wrong label used in the supplied luer systems boxes ¿ the label designated the content as male nrfit connection.The contents of the boxes are the desired luer connection, but the item name is incorrect.There was no patient involvement.
Additional Manufacturer Narrative
B3: unknown; no information has been provided to date.H3: 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 reportable information becomes available.
Additional Manufacturer Narrative
D1-d4 updated; g4 updated; h4 updated; b3 updated; h5 corrected; h8 corrected.No product was returned; therefore, no visual and functional tests were performed, the reported complaint could not be confirmed, and the root cause could not be determined.If the product is returned, the manufacturer will reopen this complaint for further investigation.
Additional Manufacturer Narrative
D9: product received 6/25/2025.H3/h6: product was received for evaluation.The reported issue was that the package contained in the shipping box did not match the shipping box label.The investigation was not able to confirm the complaint allegation.Defects were not found during the inspection in the part number in the pouch against the samples inside.Reported problem was not confirmed since the device inside of the pouch corresponded to the part number printed.This failure was not generated during the manufacturing process.

• Brand Name: NRFIT ADMINISTRATION SET
• Common Device Name: SET, IV, FLUID TRANSFER
• Manufacturer (Section D): SMITHS HEALTHCARE MANUFACTURING S.A. DE C.V.; ave calidad no. 4, parque; tijuana MN ; MX
• Manufacturer Contact: reed covert ; 6000 nathan lane north; minneapolis, MN 55442 ; 2247062300
• MDR Report Key: 21859335
• Report Number: 3012307300-2025-04503
• Device Sequence Number: 12741898
• Product Code: LHI
• UDI-Device Identifier: 10610586044748
• UDI-Public: (01)10610586044748(17)270213(10)6093419
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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: User Facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/03/2025

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 Catalogue Number: 21-7624-24
• Device Lot Number: 6093419
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/21/2025
• Supplement Date Received by Manufacturer: 04/23/2025; 08/05/2025
• Initial Report FDA Received Date: 04/17/2025
• Supplement Report FDA Received Date: 05/23/2025; 09/03/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/02/2025
• 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