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	11/01/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A complaint was received on (b)(6) 2022 reporting substance on 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.
Event or Problem Description
Substance on tubing.
Additional Manufacturer Narrative
A sample of the tubing was provided to deroyal for evaluation and a picture of the tubing was supplied to (b)(4).A supplier corrective action request (scar) was issued to the tubing supplier (b)(4).Root cause: was determined to be unknown by the supplier (b)(4).As specific defective samples have not been obtained.It was impossible to determine what the substance was, and in which link the substance was produced.Potential root cause determined by (b)(4): the reason why the bad samples entered the market is that we did not find the bad samples in time and pick them out.There may be some material on it due to negligence of employees in the production process, but there is no such material in our production environment.The following corrective and preventive actions have taken place by (b)(4): relevant quality personnel and production personnel have been trained, and the subsequent production process is required to increase the sampling amount for inspection, and the appearance of packaging products is also required to be inspected.We checked the retention samples, the inventory, and the products under production, and found no such problems.Strengthen the appearance inspection of the products to 100% inspection, packaging needs to check the appearance before packaging.The inspection of the other types of products has also been strengthened, and packaging can only be carried out after 100% complete inspection.Production records were reviewed, and no issues were found.An inventory check of the tubing was made by deroyal, a total of 80 of the 5-3279 tubing was 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 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: 15869508
• Report Number: 3005011024-2022-00038
• Device Sequence Number: 5209106
• Product Code: LRO
• UDI-Device Identifier: 00749756366304
• UDI-Public: 00749756366304
• 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): 01/06/2023

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: 89-10581
• Device Catalogue Number: 89-10581
• Device Lot Number: 57603751
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 11/01/2022
• Supplement Date Received by Manufacturer: 11/01/2022
• Initial Report FDA Received Date: 11/28/2022
• Supplement Report FDA Received Date: 01/06/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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