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	01/10/2023
Type of Reportable Event	Malfunction
Event or Problem Description
Long hair wrapped in the suction tubing.
Additional Manufacturer Narrative
A complaint was received on (b)(6) 2023 reporting long hair wrapped in the suction tubing.A supplier corrective action request (scar) was issued to the tubing supplier amsino international, inc.The sample has not been returned to deroyal for evaluation at this time.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.
Additional Manufacturer Narrative
A complaint was received on 01/26/2023 reporting long hair wrapped in the suction tubing.A supplier corrective action request (scar) was issued to the tubing supplier (b)(4).A picture of the sample was provided to deroyal for evaluation.Root cause was determined by the supplier (b)(4), inc.To be the staff did not dress and wear hair nets as required during the production of the product.The long hair wrapped in the tubing was an isolated incident.The following corrective and preventive actions have taken place by (b)(4): relevant quality personnel and production personnel have been trained.Reserved samples were checked, and no hair was found on the product.Amsino also checked the inventory and the products under production, found no such problems.They will check the dress of the staff and will strengthen the control of nonconformity products.Production records were reviewed, and no issues were found.An inventory check of the tubing was made by deroyal, a total of 50 of the 5-3279 were inspected, and no discrepancies were identified during the inspection.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: 16277760
• Report Number: 3005011024-2023-00007
• Device Sequence Number: 15171243
• 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): Unknown
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/20/2023

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: 58207151
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/26/2023
• Supplement Date Received by Manufacturer: 01/26/2023
• Initial Report FDA Received Date: 02/01/2023
• Supplement Report FDA Received Date: 03/20/2023
• 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