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

Model Number	89-10540
Medical Device Problem Code	Contamination /Decontamination Problem (2895)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/19/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A user facility medwatch report (#(b)(4)) was received on 02/22/2023 reporting a hair found in the blue towel of carotid pack.A supplier corrective action request (scar) was issued to the towel supplier gd medical.The actual sample was not available to be returned to deroyal for evaluation.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.
Event or Problem Description
A hair found in the blue towel of carotid pack.
Additional Manufacturer Narrative
A user facility medwatch report (#(b)(4)) was received on 02/22/2023 reporting a hair found in the blue towel of carotid pack.The actual sample was not available to be returned to deroyal for evaluation.A supplier corrective action request (scar) was issued to the towel supplier gd medical.Root cause was determined by the supplier gd medical to be a certain employee in the folding workshop was not properly following the gowning procedure.The following corrective and preventive actions have been taken by gd medical: employees in the folding workshop were re-trained on the gowning procedure to avoid any hair left on the products.Workshop supervisors have been notified of this incident.They will monitor and provide guidance on proper gowning of each worker during production.Supervisors and quality assurance of the other manufacturing process have been notified of this incident.Quality assurance will pay attention to any reoccurrence of the same issue during in-process and finished product inspections.Production records were reviewed, and no issues were found.An inventory check of the towel was made by deroyal, a total of 32 of the 5-5042 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 CAROTID 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
• MDR Report Key: 16573811
• Report Number: 3005011024-2023-00013
• Device Sequence Number: 7234683
• Product Code: LRO
• UDI-Device Identifier: 00749756364003
• UDI-Public: 00749756364003
• 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): 04/10/2023

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: 89-10540
• Device Catalogue Number: 89-10536
• Device Lot Number: 57751366
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 02/22/2023
• Supplement Date Received by Manufacturer: 02/22/2023
• Initial Report FDA Received Date: 03/20/2023
• Supplement Report FDA Received Date: 04/10/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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