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

Model Number 89-10543

Device Problem Material Puncture/Hole (1504)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/07/2023

Event Type  malfunction  

Event Description

Hole in outer wrapper.

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
• Type of Device: 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
• MDR Text Key: 313667457
• Report Number: 3005011024-2023-00023
• Device Sequence Number: 1
• Product Code: LRO
• UDI-Device Identifier: 00749756363525
• UDI-Public: 00749756363525
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K842648
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 04/19/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/20/2023
• 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
• Date Manufacturer Received: 03/23/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1