MAUDE Adverse Event Report: DEROYAL INDUSTRIES, INC.. CCASC LAPAROTOMY PACK; GENERAL SURGERY TRAY

Model Number	89-10558
Medical Device Problem Code	Contamination (1120)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/01/2025
Type of Reportable Event	Malfunction
Event or Problem Description
A user facility through a medwatch, "hair on asepto bulb in laparotomy pack.".
Additional Manufacturer Narrative
A user facility through a medwatch, "hair on asepto bulb in laparotomy pack.".
Additional Manufacturer Narrative
A user facility reported, "hair on asepto bulb in laparotomy pack." deroyal industries, inc.Requested return of the device and received it on 12/16/2025.Upon inspection, the issue was confirmed.The work order was reviewed for the lot on the complaint and no issues were found.No inventory was able to be inspected as the lafollette branch plant has closed and no inventory is available or being made.A previous corrective and preventative action (capa) was closed in august for similar issues.Root cause: no issues were found within the work order.Therefore, based on that and the previous capa, the true root cause 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.Several correctives were taken including: gowning reinforcement-new supplier of hair nets and beard covers, heightened inspection- management has developed a process for bin counting, and cleaning and sanitation-filtration system for clean rooms changed and curtains were installed for windows between manufacturing and boxing departments to prevent cross-contamination.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 information becomes available.

• Brand Name: CCASC LAPAROTOMY 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 ; 8653622106
• MDR Report Key: 23815362
• Report Number: 3005011024-2025-00016
• Device Sequence Number: 21323033
• Product Code: LRO
• UDI-Device Identifier: 00749756364430
• UDI-Public: 00749756364430
• 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: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/18/2025

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
• Operator of Device: Health Professional
• Device Model Number: 89-10558
• Device Lot Number: 62541646
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/08/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 12/16/2025
• Supplement Report FDA Received Date: 12/18/2025
• 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
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown