MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. NRFIT ADMINISTRATION SET; SET, IV, FLUID TRANSFER

Catalog 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	11/01/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
E1: facility name (b)(6).H3: the customer provided one photo that confirms the customer reported issue.The sample was not returned.In case the sample was provided the complaint will be re-open to evaluate the device and make the corresponding tests.Retrospective review was performed for lot number 4440901, for a period of december 2023 to december 2024 and no complaints with the same lot were affected or by the same condition.
Event or Problem Description
It was reported that the product started leaking.The medicine ended up on the floor and not in the hose.There was unknown patient involvement.No patient harm/adverse event was reported.

• Brand Name: NRFIT ADMINISTRATION SET
• Common Device Name: SET, IV, FLUID TRANSFER
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 6000 nathan lane north; minneapolis MN 55442
• Manufacturer Contact: reed covert ; 6000 nathan lane north; minneapolis, MN 55442 ; 2247062300
• MDR Report Key: 21021445
• Report Number: 3012307300-2024-15485
• Device Sequence Number: 4223365
• Product Code: LHI
• UDI-Device Identifier: 10610586044748
• UDI-Public: (01)10610586044748(17)251122(10)4440901
• Combination Product (Y/N): N
• Initial Reporter Country: SW
• 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
• Report Date (Section B): 12/26/2024

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: 11/22/2025
• Device Catalogue Number: 21-7624-24
• Device Lot Number: 4440901
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/29/2024
• Initial Report FDA Received Date: 12/26/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/15/2023
• 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