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

Model Number	89-10558
Medical Device Problem Code	Contamination /Decontamination Problem (2895)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/28/2021
Type of Reportable Event	Malfunction
Event or Problem Description
Paper clip found inside unopened pack.Pack was not opened to remove paper clip.
Additional Manufacturer Narrative
A user facility medwatch report (#(b)(4)) was received on 02/17/2022 reporting paper clip found inside unopened pack.Pack was not opened to remove paper clip.The sample was returned to deroyal for evaluation.The root cause has been determined to be a random event due to the employee's inattentiveness during the manufacturing process as an oversight.Corrective action: the manufacturing employees responsible for this oversight, has been retrained on acd.Qlp.034 work order processing procedure.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: CCASC 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
• Manufacturer Contact: melissa logsdon ; 200 debusk lane; powell, TN 37849 ; 8653626157
• MDR Report Key: 13559180
• Report Number: 3005011024-2022-00009
• Device Sequence Number: 3788737
• Product Code: LRO
• UDI-Device Identifier: 00749756364430
• UDI-Public: 00749756364430
• 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): 02/18/2022

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: 89-10558
• Device Catalogue Number: 89-10558
• Device Lot Number: 55971074
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/21/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/17/2022
• Initial Report FDA Received Date: 02/18/2022
• 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