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

Catalog Number	CIT5905
Medical Device Problem Code	Sharp Edges (4013)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/08/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that straight hemo defective with sharp point at end.
Additional Manufacturer Narrative
The customer reported finding a defective hemostat, and the detailed description of the concern was "straight hemo defective with sharp point at end." a photo and a sample were received; evaluation found 1 ea hemostat without the rest of the kit, and the end of the tip on the right side of the hemostat does come to a point and is sharp while the end of the left is flat, with no other defects or damage observed.The reported issue was confirmed; based on the complaint details the root cause was considered to be a vendor product issue relating to the component manufacturing process, but the vendor response stated the manufacturer for this instrument cannot be identified and a root cause cannot be determined at this time.Complaint history and production records were reviewed, no other reports of a hemostat with a sharp point were identified, and the incident appears to be isolated.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: CIRC 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: 50934387
• Report Number: 1824619-2026-00125
• Device Sequence Number: 18516218
• Product Code: OHG
• UDI-Device Identifier: 10653160283355
• UDI-Public: 10653160283355
• Combination Product (Y/N): N
• Initial Reporter State: MI
• 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): 09/28/2026

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: CIT5905
• Device Lot Number: 22LBA155
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 05/15/2023
• 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: 05/08/2023
• Initial Report FDA Received Date: 09/29/2026
• 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