MAUDE Adverse Event Report: Centurion Medical Products, LP CENTURION; LACERATION TRAY

Catalog Number	SUT10520
Medical Device Problem Code	Corroded (1131)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/09/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that "they opened the package and the instruments were full of rust.".
Additional Manufacturer Narrative
The customer reported finding instruments full of rust in a laceration tray.A photo was received for investigation; finished good production records were reviewed and no non-conformances were noted by production or quality control personnel during first article, in-process, or case packaging inspections, and the bom was reviewed and no issues were identified.An examination of the photographs confirmed the report as rust could be seen on the instruments shown.Based on the available information, the issue is attributable to a broken lidocaine ampoule; with the above information the investigation is unable to determine a root cause, and monitoring of the situation will continue through 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: LACERATION 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: 50818254
• Report Number: 1824619-2026-00081
• Device Sequence Number: 10680820
• Product Code: LRP
• UDI-Device Identifier: 00653160364675
• UDI-Public: 00653160364675
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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): 09/16/2026

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: SUT10520
• Device Lot Number: 2022072600
• 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: 11/09/2023
• Initial Report FDA Received Date: 09/18/2026
• 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