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	03/01/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Customer reported that during aline preparation for patient, the tubing leaked at one of the connections when flushed and saline leakage at connection was recognized.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.There was no sample available for this complaint, and the lack of an available sample prevented confirmation of the reported event.Considering the investigation results, a root cause cannot be positively identified; 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.
Event or Problem Description
It was reported that aline preparation for patient and the actual tubing leaked at the one of the connections when flushed.Prepped aline for insertion and confirmed line was flushed recognized saline leakage at connection.

• Brand Name: CENTURION
• Common Device Name: YNHH ARTERIAL LINE INSERTION TRAY
• Manufacturer (Section D): Medline Industries, LP; three lakes drive; northfield IL 60093 -275
• Manufacturer Contact: sangameswaran saravanakumar ; three lakes drive; northfield, IL 60093--275
• MDR Report Key: 50854732
• Report Number: 1417592-2026-47571
• Device Sequence Number: 21206837
• 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

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Catalogue Number: ART685
• Device Lot Number: 2023112790
• Was Device Available for Evaluation?: No
• 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: 03/01/2024
• 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
• Patient Sequence Number: 1
• Patient Sex: Unknown