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

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	08/01/2025
Type of Reportable Event	Malfunction
Event or Problem Description
A user facility reported, "spot noted on table drape after opening pack.".
Additional Manufacturer Narrative
A user facility reported, "spot noted on table drape after opening pack." deroyal industries, inc.Requested return of the device, but it was not received.Due to a trend of similar complaints from january 2025, an investigation was launched to ensure any and all corrective actions were taken to mitigate the issue.Throughout the investigation, assembly processes were reviewed as well as production records.Suppliers were also consulted and interviewed to determine any issues on the vendor side.Root cause: while the true root cause of debris/particulate & hair contamination within the packs was unable to be determined, possible root causes may have been inattention to detail while doing visual inspection of components placed within the pack.Vendor related concealed within folds of the components.Increased movement where the raw materials are located.Corrective and preventive actions: there was an increase to the gowning reinforcement including a new supplier of hair nets and beard covers.The filtration system for the clean rooms was changed to help with cleaning and sanitation.Curtains for windows between manufacturing and boxing departments were also installed to prevent cross-contamination.Inspections were also heighted with a newly developed process for bin counting.This process helps for pre-counting small items and therefore increasing the inspection on these items.Deroyal will continue to monitor for trends around this item and issue.This 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
• 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
• MDR Report Key: 22885171
• Report Number: 3005011024-2025-00012
• Device Sequence Number: 21030235
• 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): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 08/25/2025

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
• Operator of Device: Health Professional
• Device Model Number: 89-10581
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/20/2025
• Initial Report FDA Received Date: 08/25/2025
• 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