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

Model Number	89-10543
Medical Device Problem Code	Material Puncture/Hole (1504)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/07/2023
Type of Reportable Event	Malfunction
Event or Problem Description
Hole in outer wrapper.
Additional Manufacturer Narrative
A user facility medwatch report (#4900240000-2023-8056), was received on 4/10/2023, reporting hole in outer wrapper.The actual sample has not been returned to deroyal for evaluation at this time.A potential root cause has been identified but is not limited to the following: mishandling of the tray from caser or unknown source at some point prior to use.Corrective action: this incident was reviewed with the production supervisors, due to employee is no longer employed by deroyal.Preventive action: weekly inspections are being performed by maintenance to inspect all manufacturing surfaces for potential hazards to outer packaging.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: CARDIAC LINEN 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: 16775414
• Report Number: 3005011024-2023-00023
• Device Sequence Number: 17896279
• Product Code: LRO
• UDI-Device Identifier: 00749756363525
• UDI-Public: 00749756363525
• 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): 04/19/2023

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: 89-10543
• Device Catalogue Number: 89-10543
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/23/2023
• Initial Report FDA Received Date: 04/20/2023
• 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