MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. NRFIT CONNECTOR SET; ADMINISTRATIONS SETS WITH NEURAXIAL CONNECTORS

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	10/01/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that, when the pcea is connected, an alarm sounds, which is thought to be due to a blockage.After replacing it with another extension tube, there are no problems.This occurred during priming at the facility.There was no patient involvement.
Additional Manufacturer Narrative
E1: (b)(6).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 information becomes available.
Additional Manufacturer Narrative
One device was returned for analysis.As received, no damages or anomalies were observed.No errors or alarms were observed, and no leakage was noted during testing and issue was not replicated.The complaint of alarming when connected could not be replicated or confirmed.

• Brand Name: NRFIT CONNECTOR SET
• Common Device Name: ADMINISTRATIONS SETS WITH NEURAXIAL CONNECTORS
• 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: 20589767
• Report Number: 3012307300-2024-12562
• Device Sequence Number: 21031861
• Product Code: PWH
• UDI-Device Identifier: 10610586044113
• UDI-Public: (01)10610586044113(17)260214(10)4461386
• 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,Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/03/2025

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 Expiration Date: 02/14/2026
• Device Catalogue Number: 21-7605-24
• Device Lot Number: 4461386
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/23/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/07/2024
• Supplement Date Received by Manufacturer: 12/07/2024
• Initial Report FDA Received Date: 11/01/2024
• Supplement Report FDA Received Date: 01/03/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/28/2024
• 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