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

Model Number	89-10536
Medical Device Problem Code	Contamination /Decontamination Problem (2895)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/01/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The sample was not returned for evaluation.It was reported by the customer that the sample was thrown away.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, equipment has loose particulate, inadequate customer satisfaction follow-up, possible inadequate controls identified, possible inadequate assembly methods / instructions, and debris contained in vendor supplied items.The following corrective actions have taken place: 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, internal supplier personnel were confirmed to be trained on the cleaning and sanitation procedure, supplier corrective action request (scar) was issued to the lab coat supplier, corrective and preventive action point (capa) (b)(4) has been assigned, sub-assemblies were created to place all items potentially containing/attracting lint together prior to final assembly, 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.
Event or Problem Description
Speck of dust found in the (cmc av fistula pack).It was found before the patient got in the room.The pack was closed and thrown away.Information was received from the unit director the staff stated particles was noted on the left side of pack after opening.

• Brand Name: CMC AV FISTULA PACK
• Common Device Name: GENERAL SURGERY TRAY (KIT)
• Manufacturer (Section D): DEROYAL INDUSTRIES, INC.; 1501 east central avenue; lafollette TN 37766
• MDR Report Key: 12598476
• Report Number: 3005011024-2021-00011
• Device Sequence Number: 4270739
• Product Code: LRO
• UDI-Device Identifier: 00749756364003
• UDI-Public: 00749756364003
• 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): 10/08/2021

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: No Information
• Device Model Number: 89-10536
• Device Catalogue Number: 89-10536
• Device Lot Number: 54011590
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/29/2021
• Initial Report FDA Received Date: 10/08/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1