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

Model Number	5-18129-ACS
Medical Device Problem Codes	Loss of or Failure to Bond (1068); Material Integrity Problem (2978)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/24/2023
Type of Reportable Event	Malfunction
Event or Problem Description
The sponge portion of sponge stick in the prep tray fell off in the patient while prepping.
Additional Manufacturer Narrative
A complaint was received on (b)(6) 2023 reporting the sponge portion of sponge stick in the prep tray fell off in the patient while prepping.A supplier corrective action request (scar) was issued to the prep sponge supplier welmed.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.
Additional Manufacturer Narrative
A complaint was received on 02/24/2023 reporting the sponge portion of sponge stick in the prep tray fell off in the patient while prepping.The actual sample was not available to be returned to deroyal for evaluation.A supplier corrective action request (scar) was issued to the prep sponge supplier welmed.Root cause was determined by the supplier welmed to be the standard operating procedure did not specify the disposal method of the product during the machine commissioning period.The following corrective and preventive actions have been taken by welmed: quality assurance checked the equipment parameters of the on-site welding machine and found that the equipment parameters were in compliance with the verification documents.Conducted containment and tensile tests on the products in the inventory, and no such phenomenon was found.Test data of retained samples shows the product passed the tensile test.Added a disposal method of the product during the debugging period in the standard operating procedure: all the products during the debugging period are discarded as scrap, the first 10 molds are scrapped after the debugging is qualified, and the 11th mold starts to be used for the first article inspection.Continuously track the welding conditions of three batches of sponge stick products to ensure effective corrective and preventive measures.Production records were reviewed, and no issues were found.An inventory check of the sponge stick was made by deroyal, a total of 10 of the 5-17930 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: PREP TRAY
• 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: 16573687
• Report Number: 3005011024-2023-00014
• Device Sequence Number: 15246400
• Product Code: LRO
• UDI-Device Identifier: 00749756864848
• UDI-Public: 00749756864848
• Combination Product (Y/N): N
• Initial Reporter State: IA
• Initial Reporter Country: US
• 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): 04/18/2023

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: 5-18129-ACS
• Device Catalogue Number: 5-18129-ACS
• 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: 02/24/2023
• Supplement Date Received by Manufacturer: 02/24/2023
• Initial Report FDA Received Date: 03/20/2023
• Supplement Report FDA Received Date: 04/18/2023
• 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