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

Model Number	89-10578
Medical Device Problem Code	Material Puncture/Hole (1504)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/12/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A user facility medwatch report (# (b)(4)) was received on 06/02/2022 reporting hole in outer blue drape, did not penetrate plastic bag.A photo of the hole in outer blue drape was provided to deroyal for evaluation.Potential root cause: it is possible that it may be the placement of the graduate pitcher handle.The placement of the graduate pitcher handle needs to be turned different inside the tray, to prevent holes in the back table cover.Corrective action: quality control specialist contacted tray engineering to evaluate the tray for a placement change on the graduate with handle.With emphasis on the way the handle is turned inside the tray to prevent holes in the back table cover.Engineering change order number (b)(4) has been created to update the routing on the graduate.Preventive action: weekly inspections are being performed by supervisors and maintenance to inspect all manufacturing surfaces for potential hazards to outer packaging.Complaint trends are being monitored to verify effectiveness of action taken.An inventory check was made by deroyal, a total of 50 back table covers 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.
Event or Problem Description
Hole in outer blue drape, did not penetrate plastic bag.

• Brand Name: CMC VASCULAR ACCESS 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: 14832096
• Report Number: 3005011024-2022-00024
• Device Sequence Number: 2382449
• Product Code: LRO
• UDI-Device Identifier: 00749756363495
• UDI-Public: 00749756363495
• 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): 06/27/2022

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: 89-10578
• Device Catalogue Number: 89-10578
• Device Lot Number: 56729482
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/24/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/02/2022
• Initial Report FDA Received Date: 06/27/2022
• 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