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	02/01/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A complaint was received on 02/03/2023 reporting hole in pack.The sample has not been returned to defrayal for evaluation at this time.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
Hole in pack.
Additional Manufacturer Narrative
A complaint was received on 02/03/2023 reporting hole in pack.The sample was not returned for evaluation.The reported issue could not be confirmed.Potential root cause has been identified but are not limited to the following: mishandling of the pack during transit or at some point prior to use.The pouch was snagged on the tables during the manufacturing process.Mishandling of the product during the placement of the tray within shipping case.Mishandling of the product during retrieval of the product from the customer's storage, location or during the set-up process.Corrective action: this incident was reviewed with the production supervisors.Preventive action: weekly inspections are being performed by maintenance to inspect all manufacturing surfaces for potential hazards to outer packaging.Complaint trends are being monitored to verify effectiveness of action taken.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
• Manufacturer Contact: melissa logsdon ; 200 debusk lane; powell, TN 37849 ; 8653626157
• MDR Report Key: 16408643
• Report Number: 3005011024-2023-00008
• Device Sequence Number: 12297674
• 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): Unknown
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/22/2023

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
• Device Lot Number: 58214669
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/03/2023
• Supplement Date Received by Manufacturer: 02/03/2023
• Initial Report FDA Received Date: 02/21/2023
• Supplement Report FDA Received Date: 03/22/2023
• 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