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

Model Number	89-10581
Medical Device Problem Code	Contamination /Decontamination Problem (2895)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/17/2022
Type of Reportable Event	Malfunction
Event or Problem Description
Debris found in bucket with handle.New pack obtained before patient entered the operating room.
Additional Manufacturer Narrative
A user facility medwatch report (b)(4) was received on (b)(6) 2022 reporting debris found in bucket with handle.New pack obtained before patient entered the operating room.The sample is not available to be returned to deroyal for evaluation.Potential root cause: it was determined, but not limited to, possible employee failure to identify debris, possible dress code violation, lack of lab coat cleanliness, cleaning process not followed or inadequate, exposed product in warehouse, natural occurring static, and equipment has loose particulate.The following corrective actions have taken place by deroyal: manufacturing personnel were retrained on the dress code procedure (corp.Prc.079) and cleaning procedure (corp.Prc.086), quality control specialist started conducting routine walk-throughs in raw material storage areas to identify any potentially exposed product, manufacturing personnel were instructed to wipe down production lines after every order, supplier corrective action request (scar) was issued to the lab coat supplier, corrective and preventive action point (capa) (b)(4) has been assigned, and added additional guidance to the manufacturing instructions to indicate that these products have had reports of debris to increase scrutiny during the assembly process.The deroyal sales representative conducted an initial site visit on 08/12/2021 in regards to reported complaints of contamination (hair and debris) in procedure trays and collected various defective product samples.The samples were provided in bulk and were not able to be correlated to the corresponding reported quality events.The sales representative performed a follow-up visit on 08/19/2021, and the customer agreed to individually bag each separate complaint sample in the future.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: CMC VASCULAR 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: 13652846
• Report Number: 3005011024-2022-00012
• Device Sequence Number: 17580090
• Product Code: LRO
• UDI-Device Identifier: 00749756366304
• UDI-Public: 0749756366304
• 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): 03/02/2022

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: 89-10581
• Device Lot Number: 55506201
• Was Device Available for Evaluation?: No
• 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: 03/02/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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