MAUDE Adverse Event Report: DEROYAL INDUSTRIES, INC. BREAST BIOPSY TRAY; GENERAL SURGERY TRAY (KIT)

Model Number	70-10770
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Needle Stick/Puncture (2462)
Date of Event	03/02/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A supplier corrective action request (scar) was issued to the needle supplier (b)(4).The sample has not been returned to deroyal for evaluation at this time.An inventory check was made by deroyal, a total of 50 needles were inspected, and no discrepancies were identified during the inspection.This investigation is ongoing at this time.No further information is available at this time.We will provide follow-up report if additional information becomes available.
Event or Problem Description
Having breakage trouble with the item 5-9043 needle within this tray.We had a 30g needle, which was part of the same lot number, break off in a patient's breast.This patient is having surgery for breast cancer in the opposite breast, and will have the needle removed at that time, in the other breast.She had 2 biopsies the day this happened.She is having an unnecessary surgery due to the needle breaking off.
Additional Manufacturer Narrative
A supplier corrective action request (scar) was issued to the needle supplier becton - dickinson.Representative samples were received and evaluated.Root cause: the supplier becton - dickinson was unable to determine the true root cause.Visual inspection was performed on the representative samples with a 10x magnifier lens.No defects or imperfections were observed.Then an inspection was performed with a 30x microscope.No defects or imperfections were observed.Corrective action: a corrective action has not been taken due to the root cause determination.A trend analysis was done for this product by becton-dickinson.This is the only complaint for this symptom from this and any other customer during the last 3 years.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: BREAST BIOPSY TRAY
• 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: 14015477
• Report Number: 3005011024-2022-00015
• Device Sequence Number: 4559410
• Product Code: LRO
• UDI-Device Identifier: 00749756194686
• UDI-Public: 0749756194686
• Combination Product (Y/N): N
• Initial Reporter State: AR
• 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): Unknown
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/02/2022

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: 70-10770
• Device Lot Number: 55967471
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/22/2022
• Supplement Date Received by Manufacturer: 03/22/2022
• Initial Report FDA Received Date: 04/05/2022
• Supplement Report FDA Received Date: 05/03/2022
• 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