MAUDE Adverse Event Report: DEROYAL INDUSTRIES, INC. CMC VASCULAR PACK; GENERAL SURGERY TRAY (KIT)

Model Number	89-10581
Medical Device Problem Code	Contamination /Decontamination Problem (2895)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/28/2025
Type of Reportable Event	Malfunction
Event or Problem Description
Hair was noted on the end of the bovie pencil.
Additional Manufacturer Narrative
A user facility medwatch report ((b)(4)) was received on 05/28/2025 reporting hair was noted on the end of the bovie pencil.The sample has not been returned to deroyal for evaluation at this time.A supplier corrective action request (scar) was issued to the pencil supplier covidien.This investigation is ongoing at this time.No further information is available at this time.We will provide follow-up report if additional information becomes available.
Additional Manufacturer Narrative
A user facility medwatch report (b)(4) was recieved on 5/28/2025 reporting hair was noted on the end of the bovie pencil.Deroyal industries, inc.Requested return of the device, however it was not returned.A picture of the sample was received and was noted to have a hair on the bovie pencil.Deroyal conducted a review of the work order and found no discrepancies or deviations from standard manufacturing procedures.An inventory check was performed on (b)(4) units of the raw material pencils and no defects were discovered.A complaint to sales ratio was conducted over the past two years and found to be (b)(4).A supplier corrective action request (scar) was issued to the pencil supplier, covidien.The supplier reviewed the photo of the sample and also confirmed the hair and noted it looked like hair was taped to the device.Without the supplier receiving the device, a detailed investigation could not be performed and with no lot number provided the device history record could not be reviewed.Root cause: because no lot number or actual device were returned, no root cause was able to be determined.Corrective and preventive actions: because the root cause was unable to be determined, no corrective or preventive actions were taken.Deroyal will continue to monitor for trends around this item and issue.The investigation is complete at this time.No further information is available at this time.We will provide follow up report if additional information becomes available.

• Brand Name: CMC VASCULAR PACK
• Common Device Name: GENERAL SURGERY TRAY (KIT)
• Manufacturer (Section D): DEROYAL INDUSTRIES, INC.; 1501 east central avenue; lafollette TN 37766
• Manufacturer (Section G): DEROYAL INDUSTRIES, INC.; 1501 east central avenue; lafollette TN 37766
• Manufacturer Contact: reagan facemire ; 200 debusk lane; powell, TN 37849 ; 8653622106
• MDR Report Key: 22132903
• Report Number: 3005011024-2025-00006
• Device Sequence Number: 15546360
• Product Code: LRO
• UDI-Device Identifier: 00749756366304
• UDI-Public: 00749756366304
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: K842648
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial,Followup
• Report Date (Section B): 08/18/2025

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 Model Number: 89-10581
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 05/28/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/03/2025
• Supplement Report FDA Received Date: 08/18/2025
• 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
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown