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

Catalog Number	ART685
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/25/2024
Type of Reportable Event	Other
Event or Problem Description
It was reported that a-line monitoring extension set (high pressure tube with one way stopcock) had a crack/leaking.Unable to properly flush or get accurate readings of pt's blood pressure due to leak in high pressure extension tubing.
Additional Manufacturer Narrative
The customer reported that the a-line monitoring extension set had a crack/leaking and that they were unable to properly flush or get accurate readings of pt's blood pressure due to leak in high pressure extension tubing.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 completed the investigation based on all provided information, the returned sample, and the provided product information.Based on analysis of the returned sample, the complaint of a inability to flush the extension tube is confirmed; functional testing of the extension tube revealed a complete occlusion within the luer connector, and no leaks or cracks in the extension set were observed during evaluation.Inspection of the luer connector revealed the interior diameter was occluded with what appeared to be a clear material which likely occurred during device manufacture, and the division will continue to monitor this issue and will initiate corrective actions if a trend is identified.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
• Manufacturer Contact: narendra nambula ; three lakes drive; northfield, IL 60093--275
• MDR Report Key: 50853183
• Report Number: 1417592-2026-47314
• Device Sequence Number: 9953970
• 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: 05/02/2024
• 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: 04/25/2024
• Initial Report FDA Received Date: 09/22/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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