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

Model Number	89-6015
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	06/01/2018
Type of Reportable Event	Malfunction
Event or Problem Description
During closing count it was noticed that there was 2 needles stuck together causing the count to be over by 1 needle.We counted all sharps and sponges before the surgery.It was a manufacturing defect that caused the incorrect count.It could not be noticed until the needle was about to be loaded on needle driver.An x-ray was taken by doctors and confirmed that the x-ray was negative for retained foreign body.

• Brand Name: DEROYAL
• Common Device Name: GENERAL SURGERY TRAY
• Manufacturer (Section D): DEROYAL INDUSTRIES, INC.; 200 debusk lane; powell TN 37849
• MDR Report Key: 7605132
• Report Number: 7605132
• Device Sequence Number: 11237243
• Product Code: FSM
• UDI-Device Identifier: 00749756654531
• UDI-Public: (01)00749756654531
• Combination Product (Y/N): N
• Initial Reporter State: RI
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 06/05/2018
• Report Date (Section F): 06/05/2018

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: Physician
• Device Model Number: 89-6015
• Was the Report Sent to FDA?: Yes
• Device Age: 1 DY
• Event Location: Hospital
• Date Report to Manufacturer: 06/05/2018
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/15/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Date Report Sent to FDA: 06/05/2018