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	10/17/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A user facility medwatch report (b)(4) was received reporting hair found inside sterile package.The sample was received, and it was determined that the hair was found inside the vessel loop package that deroyal purchases from aspen surgical product.A supplier corrective action request (scar) was issued to the vessel loop supplier aspen surgical product.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
Hair found inside sterile package.
Additional Manufacturer Narrative
A user facility medwatch report (b)(4) was received reporting hair found inside sterile package.The sample was received, and it was determined that the hair was found inside the vessel loop package that deroyal purchases from aspen surgical product.A supplier corrective action request (scar) was issued to the vessel loop supplier aspen surgical product.Root cause was determined by the supplier aspen surgical product several factors were identified that may have contributed to the presence of a hair on the finished product.A need was identified to reinforce the proper use of personal protective equipment (ppe), including optimizing the gowning sequence.It was also identified that the current layout of the gowning area could benefit from adjustments that would favor a more efficient distribution and allow for more effective supervision of this process.The following corrective and preventive actions have been taken by aspen surgical product updating and strengthening of the gowning instruction 1078686.Update of visual aids in and out of area 1076820 where -implementing changes in the gowning process, as well as a second use of lint roller.Training of personnel in the gowning process 1078686.Change of material in the gowns used in the area from tyvek to polyester, which prevents hair and particles from adhering to the surface of the gown.Redesign of the area gowning layout.Modification of the control plan to add visual inspection of hair contamination.Quality alert issued.Production personnel were notified of the reported complaint.Replacement of air purifier sponges.Change of cleaning frequency from once to twice, once in the morning before starting shift and once after lunch.Deroyal conducted re-training on the workorder procedure to ensure the employees are aware of this complaint and the importance of checking products for hair/debris/defects.Production records were reviewed, and no issues were found.An inventory check of the vessel loops was made by deroyal, a total of 50 of the 1260701 was 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
• Manufacturer Contact: melissa logsdon ; 200 debusk lane; powell, TN 37849 ; 8653626157
• MDR Report Key: 20608667
• Report Number: 3005011024-2024-00014
• Device Sequence Number: 15436297
• Product Code: LRO
• UDI-Device Identifier: 00749756364454
• UDI-Public: 00749756364454
• 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): 02/12/2025

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: 89-10540
• Device Lot Number: 60953129
• 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: 10/17/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/05/2024
• Supplement Report FDA Received Date: 02/12/2025
• 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