MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. NRFIT CONNECTOR; SET, I.V. FLUID TRANSFER

Catalog Number	21-7605-24
Medical Device Problem Code	Obstruction of Flow (2423)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/27/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(6) 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.
Event or Problem Description
It was reported that there was a blockage during liquid delivery.Per reporter, the problem was resolved by replacing the tube and this event occurred during patient use/administration.There was patient involvement and no patient harm/adverse event reported.
Additional Manufacturer Narrative
One sample was returned for evaluation.Note: in the event description mentioned the part number: 21-7605-24 and that number does not belong to the lot number reported and the sample received.The complaint sample was visually inspected, at 12¿ to 16¿ under normal conditions of illumination.The sample returned was tested using the hydrostatic vessel, and distillated water, to verify the correct functionality of the sample.During the test the liquid does not through for the device, an occlusion was detected.According to the visual and functional test, the failure mode reported in the complaint, occluded/blockage, was confirmed.

• Brand Name: NRFIT CONNECTOR
• Common Device Name: SET, I.V. 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: 19656154
• Report Number: 3012307300-2024-05724
• Device Sequence Number: 12397121
• Product Code: LHI
• UDI-Device Identifier: 10610586044113
• UDI-Public: (01)10610586044113(17)250223(10)4376901
• 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,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/22/2024

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: 02/23/2025
• Device Catalogue Number: 21-7605-24
• Device Lot Number: 4376901
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/10/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/05/2024
• Supplement Date Received by Manufacturer: 07/24/2024
• Initial Report FDA Received Date: 07/02/2024
• Supplement Report FDA Received Date: 08/22/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/11/2023
• 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