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	11/14/2022
Type of Reportable Event	Malfunction
Event or Problem Description
Pitcher had black spots.
Additional Manufacturer Narrative
A user facility report (b)(4) was received on 12/08/2022 reporting pitcher had black spots.A supplier corrective action request (scar) was issued to the pitcher supplier royal precision plastics.The sample has not been returned to deroyal for evaluation at this time.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
The sample was provided to deroyal for evaluation.The supplier corrective action request (scar) was canceled, and the complaint was forwarded to royal precision plastics for a joint investigation because they are considered an internal deroyal facility.The root cause was determined to be embedded contamination from degraded material that has broken loose and passed through with molten plastic into the molded part.Degrade occurs when plastic is sitting in a heated barrel for a prolonged period of time.No corrective actions were taken due to occasional black specks are a result of the normal injection-molding process of polyolefins and are unavoidable in relatively small quantities.As a preventive action in an effort to reduce the potential of embedded contamination, the injection-molding machine's screw is cleaned at least annually.Production records were reviewed, and no issues were found.An inventory check of the pitcher was made by deroyal, a total of 50 of the hd-395-1200-t were inspected, and no discrepancies were identified during the inspection.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 (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: melissa logsdon ; 200 debusk lane; powell, TN 37849 ; 8653626157
• MDR Report Key: 16086302
• Report Number: 3005011024-2022-00051
• Device Sequence Number: 2034159
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/13/2023

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
• Device Catalogue Number: 89-10581
• Device Lot Number: 57603751
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/08/2022
• Supplement Date Received by Manufacturer: 12/08/2022
• Initial Report FDA Received Date: 01/03/2023
• Supplement Report FDA Received Date: 01/13/2023
• 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