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

Model Number	89-10552
Medical Device Problem Code	Contamination /Decontamination Problem (2895)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/18/2022
Type of Reportable Event	Malfunction
Event or Problem Description
We opened a sterile back table cover.It was a cmc extremity pack and we set up the table and when we poured the saline into the container, there was a hair in container.We tore down the entire back table and replaced it with new items.The patient was never in the room.New equipment was obtained.
Additional Manufacturer Narrative
A user facility medwatch report (#(b)(4)) was received on 10/24/2022 reporting the customer opened a sterile back table cover.It was a cmc extremity pack and we set up the table and when we poured the saline into the container, there was a hair in container.We tore down the entire back table and replaced it with new items.The patient was never in the room.New equipment was obtained.The sample was not returned to deroyal for evaluation.The root cause for this event was unable to be determined.There are these areas which could have contributed to hair being found within the procedure pack: 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.Per personnel dress code procedure (b)(4), 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 (b)(4), 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 or preventive actions have taken place by deroyal: manufacturing personnel were retrained on the dress code procedure ((b)(4)) and cleaning procedure ((b)(4)), 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.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 EXTREMITY 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: 15837435
• Report Number: 3005011024-2022-00032
• Device Sequence Number: 17490582
• Product Code: LRO
• UDI-Device Identifier: 00749756363549
• UDI-Public: 00749756363549
• 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): 11/21/2022

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: 89-10552
• Device Catalogue Number: 89-10552
• Device Lot Number: 57393466
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/24/2022
• Initial Report FDA Received Date: 11/21/2022
• 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