MAUDE Adverse Event Report: Centurion Medical Products, LP CENTURION; INTRO-FLEX INTRODUCER 8.5F

Catalog Number	I300F85
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	Hemorrhage/Blood Loss/Bleeding (1888)
Date of Event	01/02/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that introflex introducer set was defective as one way valve was not functional and fluid (iv & blood) was leaking out.
Additional Manufacturer Narrative
The customer reported finding the one way valve was not functional and fluid was leaking out; no medical intervention, serious injury, or follow-up care has been reported, and the procedure was able to be completed, but had to take new pcs to complete the procedure.A sample was received and evaluated, including forward pressure air ingress, freedom from leakage (valve), valve leakage (functionality) - 4f catheter, and valve leakage (functionality) - 8f catheter; finished good production records, incoming inspection records, the bom, and trending were reviewed.Based on the complaint details, sample evaluation, and investigation, the issue was confirmed because the sample failed the valve leakage (functionality) - 4f catheter test and passed the other testing completed.The cause was cannot determine cause w/received sample; the complaint was provided to the vendor for further evaluation and the issue will continue to be monitored by centurion's complaint system.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: INTRO-FLEX INTRODUCER 8.5F
• Manufacturer (Section D): Centurion Medical Products, LP; 301 catrell drive; howell MI 48843 -170
• Manufacturer Contact: shirisha mothe ; medline industries, lp; northfield, IL 60093--275
• MDR Report Key: 50884034
• Report Number: 1824619-2026-00098
• Device Sequence Number: 9799606
• Product Code: OFD
• UDI-Device Identifier: 10653160248538
• UDI-Public: 10653160248538
• Combination Product (Y/N): N
• Initial Reporter Country: NL
• 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): 09/23/2026

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: I300F85
• Device Lot Number: 2024051690
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 03/17/2025
• 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: 01/02/2025
• Initial Report FDA Received Date: 09/24/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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