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

Model Number	89-10536
Medical Device Problem Code	Component Misassembled (4004)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/23/2022
Type of Reportable Event	Malfunction
Event or Problem Description
Deroyal cmc av fistula pack contains 4-0 silk ties instead of 2-0 silk ties as stated on the packing list.
Additional Manufacturer Narrative
A user facility medwatch report (b)(4).Was received on 06/23/2022.Reporting deroyal cmc av fistula pack contains 4-0 silk ties instead of 2-0 silk ties as stated on the packing list.The sample of the 4-0 silk ties were not returned to deroyal for evaluation.Root cause: determined to be a pulling and assembly slip lapse error.Corrective action: all employees responsible for this pulling / assembly error has been retrained on, acd.Qlp.034 work order process, on specific section regarding checking components to catalog numbers for accuracy.An inventory check was made by deroyal, a total of 180 of the 2-0 silk sutures 55-3088 were inspected, and no discrepancies were identified during the inspection.Also, verified 4 components / lot numbers on batch 90480 for accuracy and correct components for the employee that made the pulling error.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 AV FISTULA 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: 14930581
• Report Number: 3005011024-2022-00026
• Device Sequence Number: 1970165
• 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): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 07/06/2022

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: 89-10536
• Device Catalogue Number: 89-10536
• Device Lot Number: 56618660
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/23/2022
• Initial Report FDA Received Date: 07/06/2022
• 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