MAUDE Adverse Event Report: DEROYAL INDUSTRIES, INC. ENT NASAL TRACEPACK; GENERAL SURGERY TRAY

Model Number	89-9341
Medical Device Problem Codes	Device Misassembled During Manufacturing /Shipping (2912); Manufacturing, Packaging or Shipping Problem (2975)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/22/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Root cause: a sample picture of the defective product was provided and confirmed that the incorrect gauze was in the convenience kit.The true root cause was identified as a pulling and assembly error.Corrective action: the puller and assembler responsible for this error were retrained on the internal work order processing procedure (acd.Qlp.034) with specific focus on the section regarding tray assembly descriptions and verifying component numbers by catalog numbers.Investigation summary: an internal complaint (call 48004) was received indicating that an ent nasal tray (finished good 89-9341, lot 49821627) contained non x-ray detectable gauze when it should have contained x-ray detectable gauze.A sample was not available for return.However, a picture of the defective sample was provided and confirmed the reported incident.The work order was reviewed for discrepancies that may have contributed to the reported event.No discrepancies were found.No shortages or defects were noted on this work order.The affected raw material was identified as component 5-20327, a 4 x 4 x-ray detectable gauze.The inventory was checked and found to be correct.No gauze was mixed on the shelf and no returns were found for the reported tray lot.The investigation is complete at this time.If new and critical information is received, this report will be updated.
Event or Problem Description
There was non x-ray detectable gauze in a convenience kit when it should have been x-ray detectable.

• Brand Name: ENT NASAL TRACEPACK
• Common Device Name: GENERAL SURGERY TRAY
• Manufacturer (Section D): DEROYAL INDUSTRIES, INC.; 1501 east central avenue; lafollette TN 37766
• MDR Report Key: 9097743
• Report Number: 3005011024-2019-00010
• Device Sequence Number: 19475001
• Product Code: LRO
• UDI-Device Identifier: 00749756913263
• UDI-Public: 00749756913263
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: K842648
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date (Section B): 09/20/2019

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
• Operator of Device: Health Professional
• Device Model Number: 89-9341
• Device Lot Number: 49821627
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/22/2019
• Initial Report FDA Received Date: 09/20/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1