MAUDE Adverse Event Report: DEROYAL INDUSTRIES, INC. ASC GENERAL PACK; GENERAL SURGERY TRAY

Model Number	89-6015
Medical Device Problem Codes	Device Misassembled During Manufacturing /Shipping (2912); Manufacturing, Packaging or Shipping Problem (2975); Component Misassembled (4004)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/21/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Root cause: a true root cause cannot be determined as a sample was not returned for evaluation and a lot number was not provided.A possible root cause of an assembly error was identified.Corrective action: supervisors were made aware of the reported incident through a notification memo.Investigation summary: an internal complaint (call (b)(4) was received indicating that a deroyal convenience kit (part number 89-6015) was in use in a procedure when the needle count was found to be off by one.The end user found two needles stuck together, which caused the count to be over by one needle.A lot number for the affected kit was not provided.The customer was contacted to obtain a lot number.However, the customer reported the kit had been discarded and no lot number could be identified.Additionally, a sample was not returned for evaluation.The complaint investigator reviewed the bill of material for the finished good and found it lists one needle each.Therefore, the count in the finished good should have been one needle.The inventory of the raw material needle was checked and no needles were found stuck together.Preventive action: due to the root cause determination, a preventive action has not been taken.The investigation is complete at this time.If new and critical information becomes available, this report will be updated.
Event or Problem Description
During closing count of a tissue removal and needle biopsy, it was noticed that two needles were stuck together, which caused the count to be over by one needle.An x-ray was taken to confirm that there was no foreign body.

• Brand Name: ASC GENERAL PACK
• Common Device Name: GENERAL SURGERY TRAY
• Manufacturer (Section D): DEROYAL INDUSTRIES, INC.; 1501 east central avenue; lafollette TN 37766
• MDR Report Key: 7707917
• Report Number: 3005011024-2018-00004
• Device Sequence Number: 13603219
• Product Code: LRO
• UDI-Device Identifier: 00749756654531
• UDI-Public: 0749756654531
• Combination Product (Y/N): N
• Initial Reporter State: RI
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 07/20/2018

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: 89-6015
• Device Lot Number: NOT PROVIDED
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/21/2018
• Initial Report FDA Received Date: 07/20/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1