MAUDE Adverse Event Report: DEROYAL INDUSTRIES, INC. CARDIAC CATH SET-UP KIT PGYBK; GENERAL SURGERY TRAY (KIT)

Model Number	89-10572
Medical Device Problem Code	Contamination /Decontamination Problem (2895)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/01/2024
Type of Reportable Event	Malfunction
Event or Problem Description
While opening for a sterile procedure, an unknown foreign item was found inside the sterile pack.
Additional Manufacturer Narrative
A user facility medwatch report (b)(4) received reporting while opening for a sterile procedure, an unknown foreign item was found inside the sterile pack.The true root cause was undetermined due to the sample not being available for return.Therefore, the foreign item could not be determined.There are these areas which could have contributed to foreign objects being found within the procedure pack: assembly not conducting a visual inspection of components and not following the (b)(4) work order process procedure.Per personnel dress code procedure corp.Prc.079, a mirror is placed in areas to allow employees to ensure that bouffant, beard covers and/or lab coats are applied appropriately.Personnel entering the clean manufacturing area shall perform the following steps prior to entering the room.Apply hair coverings, then next apply apparel, then if applicable apply shoe covers.Last step, wash or sanitize hands.Bouffant must cover all of hair.In order to contain all hair, more than one covering may be needed.Once a hair covering is removed, it must be discarded.Reapplication of the hair cover and beard/mustache cover must be with a new cover.Bouffant may not be worn outside of building.Brushing or combing of hair is not allowed in the changing room or any other area where products are handled or stored.Beard and/or mustache covers shall be worn in all areas that a bouffant hair covering is required and should cover all facial hair.Once removed, it must be discarded.Reapplication must be with a new cover.Lab coats are required in all clean manufacturing areas.Apparel / lab coats shall be buttoned/snapped.Apparel / lab coats shall be kept completely closed.Apparel / lab coats are not to be worn outside of the manufacturing area by manufacturing personnel.Per cleaning, sanitation and work environment procedure corp.Prc.086, machine operators shall ensure the work surface of each machine is free from dust, dirt, oil, debris and/or other foreign matter.All equipment used in production shall be cleaned.Garbage shall be removed daily as required by the respective cleaning checklist or form (do not transfer trash from one container to another).Daily - clean work area, work tables, manufacturing equipment, countertops and tables, empty trash, sweep floors and fatigue mats.The following corrective and preventive actions have been taken by deroyal: all employees were retrained on the acd.Qlp.034 work order process procedure.Prior to employees entering the manufacturing area they observe each other's lab coats for any foreign matter including hair and lint rollers are being used.Corp.Prc.079 dress code procedure is posted for all manufacturing to see requirements before entering the cleaning room.Manufacturing is placing their hairnets and beard covers if needed, on outside of the manufacturing room before entering the lab- coat room.Corp.Prc.086 cleaning, sanitation and work environment procedure is being followed for employees to wipe down lines before and after every order.Production records were reviewed, and no issues were found.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: CARDIAC CATH SET-UP KIT PGYBK
• 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: 20894632
• Report Number: 3005011024-2024-00017
• Device Sequence Number: 12938975
• Product Code: LRO
• UDI-Device Identifier: 00749756364065
• UDI-Public: 00749756364065
• 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): 12/10/2024

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: 89-10572
• Device Lot Number: 60663121
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/15/2024
• Initial Report FDA Received Date: 12/10/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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