MAUDE Adverse Event Report: Centurion Medical Products, LP CENTURION; DBD-BIOPSY TRAY

Catalog Number	BT150
Medical Device Problem Code	Sharp Edges (4013)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/17/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that "sharp burr on adson.".
Additional Manufacturer Narrative
The customer reported finding a sharp burr on adson that almost poked the provider as a puncture while patient's blood was on it; no injury was reported.A photo and a sample were received for the investigation, and finished good production records, finished good pack build, account complaint history, and component complaint history were reviewed.Evaluation of the returned sample confirmed the customer's report, a burr was visible on the af50ms forceps.The component manufacture for the af50ms component, hilbro international, was notified of the report and a photo was forwarded to them for evaluation; however, the results of their investigation have not yet been received and the root cause for the reported issue cannot be 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.

• Brand Name: CENTURION
• Common Device Name: DBD-BIOPSY 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: 50947525
• Report Number: 1824619-2026-00153
• Device Sequence Number: 9499262
• Product Code: LRP
• UDI-Device Identifier: 10653160291749
• UDI-Public: 10653160291749
• 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): 09/29/2026

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: BT150
• Device Lot Number: 2025031290
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 07/29/2025
• 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: 07/18/2025
• 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): 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