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

Model Number	89-10560
Medical Device Problem Code	Contamination /Decontamination Problem (2895)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/06/2023
Type of Reportable Event	Malfunction
Event or Problem Description
Red discoloration on the left side of pack when opened.
Additional Manufacturer Narrative
A user facility medwatch report (b)(4) was received on 4/6/2023 reporting red discoloration on the left side of pack when opened.The sample was not available to be returned to deroyal for evaluation.The true root cause and source of the red discoloration inside the tray was undetermined.There are areas which could have contributed to red discoloration being found within the procedure pack: possible that it was a dye discoloration from one of the components inside the tray.In response to this complaint a quality memo was issued to all assemblers to be aware of the potential of components to have dye discoloration.There have been no other complaints reported for this type of issue.Production records were reviewed, and no issues were found.An inventory check of the red needle counter was made by deroyal, a total of 25 of the 25-0403ns-t was 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: CMC LAPAROTOMY 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: 16859687
• Report Number: 3005011024-2023-00025
• Device Sequence Number: 5717917
• Product Code: LRO
• UDI-Device Identifier: 00749756363778
• UDI-Public: 00749756363778
• 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): 05/03/2023

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: 89-10560
• Device Catalogue Number: 89-10560
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/06/2023
• Initial Report FDA Received Date: 05/03/2023
• 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