MAUDE Adverse Event Report: Centurion Medical Products, LP CENTURION; YNHH ARTERIAL LINE INSERTION TRAY

Catalog Number	ART685
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	Hemorrhage/Blood Loss/Bleeding (1888)
Date of Event	05/07/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that "arterial line catheter stabilization extension set device leaking after insertion" and "arterial line flushed and fluid spewing from stabilization extension set.Assessment: upon inspection tubing noted to be cracked and blood backing back into system.".
Additional Manufacturer Narrative
The customer reported the arterial line catheter stabilization extension set device leaking after insertion; after finishing dressing, there was blood on the sterile site, fluid spewing from the stabilization extension set, tubing noted to be cracked, and blood backing back into system.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; the vendor completed the investigation based on all provided information because the actual device was not available for evaluation.The lack of an available sample prevented confirmation of the reported event and identification of the specific root cause(s), and a root cause cannot be positively identified.The event was ultimately inconclusive, with no related issues identified in manufacture quality and inspection records or complaint history, and complaints will continue to be monitored for trends.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): Centurion Medical Products, LP; 301 catrell drive; howell MI 48843 -170
• Manufacturer Contact: shirisha mothe ; three lakes drive; northfield, IL 60093--275
• MDR Report Key: 50915474
• Report Number: 1824619-2026-00115
• Device Sequence Number: 14794891
• Product Code: LRS
• UDI-Device Identifier: 10653160361824
• UDI-Public: 10653160361824
• 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): 09/25/2026

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: 2024022790
• Was Device Available for Evaluation?: Yes
• 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: 05/14/2024
• Initial Report FDA Received Date: 09/28/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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