MAUDE Adverse Event Report: Centurion Medical Products, LP CENTURION; CATHETER,STD, AVA, 3L, 9F, HF, KIC

Catalog Number	M3L9FKIC
Medical Device Problem Code	Damaged Thread (4075)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/31/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that "the issue is the obturator (light blue in color) would not advance through the catheter¿s lumen (green & white in color).When forced into the lumen of the catheter it would not lock.".
Additional Manufacturer Narrative
The customer reported finding obturator not advancing in lumen and the reported issue occurred in item m3l9fkic.A sample was received for investigation and decontaminated; the inner diameter of the catheter tube of the complaint sample and 5ea unused samples were measured, the outer diameter of the returned dilator was measured, and the returned dilator was attempted to be inserted through the returned m3l9n catheter.Medline was unable to confirm the customer's report of the dilator being difficult to insert through, but did confirm the customer's report of the dilator not locking into the catheter due to damage on the threads of the dilator.The returned samples were reviewed by a member of the centurion engineering team who noted the damage to the threads likely occurred when aggressively trying to lock the dilator into the valve assembly, and not a result of a manufacturing or inspection error; the supplier quality team will monitor this issue for trending purposes.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: CATHETER,STD, AVA, 3L, 9F, HF, KIC
• 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: 50946991
• Report Number: 1824619-2026-00148
• Device Sequence Number: 9499239
• Product Code: OES
• UDI-Device Identifier: 10653160248811
• UDI-Public: 10653160248811
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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): 09/29/2026

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: M3L9FKIC
• Device Lot Number: 2024082990
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 03/21/2025
• 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: 01/31/2025
• Initial Report FDA Received Date: 09/30/2026
• 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