MAUDE Adverse Event Report: Medline Industries, LP CENTURION; YNHH ARTERIAL LINE INSERTION TRAY

Catalog Number	ART685
Medical Device Problem Codes	Obstruction of Flow (2423); Device Contamination with Chemical or Other Material (2944)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/22/2024
Type of Reportable Event	Other
Event or Problem Description
It was reported that ¿connector tubing of aline insert kit faulty¿ and ¿when inserting aline and connected tubing, unable to flush¿; ¿when you look at tubing in light you can see what appears to be an extra piece of plastic that is causing obstruction.¿.
Additional Manufacturer Narrative
The customer reported the connector tubing of the a-line insert kit being faulty and stated that, when inserting aline and connected tubing, they were unable to flush and saw what appeared to be an extra piece of plastic causing obstruction.A review of production records did not find any similar nonconformances noted by production or quality control personnel during first article, in-process, or case packaging inspections, and the vendor of the component reported in the complaint was notified.Considering the investigation results had not been received at that time, a root cause could not be positively identified.Due diligence was completed, no additional details were available, and there was no confirmed medical intervention or serious injury reported related to this incident.There were no reports of death, serious injury, medical intervention, or follow up care.It has been determined that the reported event could cause or contribute to serious injury if it were to occur again.In an abundance of caution, this is a reportable event.If additional information becomes available this report will be reopened and reevaluated.This medical device report (mdr) is being submitted as part of retrospective review activities, which include review of historical data in accordance with regulations at 21 cfr part 803.The information included in this mdr reflects the information reasonably known to the manufacturer at the time of this retrospective review and submission.

• Brand Name: CENTURION
• Common Device Name: YNHH ARTERIAL LINE INSERTION TRAY
• Manufacturer (Section D): Medline Industries, LP; 301 catrell drive; howell MI 48843 -170
• Manufacturer Contact: abdul khan ; three lakes drive; northfield, IL 60093--275
• MDR Report Key: 50852537
• Report Number: 1417592-2026-47250
• Device Sequence Number: 15841128
• Product Code: LRO
• UDI-Device Identifier: 00653160361827
• UDI-Public: 00653160361827
• Combination Product (Y/N): N
• Initial Reporter State: CT
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Type of Report: Initial
• Report Date (Section B): 09/21/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Device Catalogue Number: ART685
• Device Lot Number: 2024012690
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 03/28/2024
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/26/2024
• Initial Report FDA Received Date: 09/22/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/01/2024
• 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
• Patient Sequence Number: 1
• Patient Sex: Unknown