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

Model Number	89-10578
Medical Device Problem Code	Contamination /Decontamination Problem (2895)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/23/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A complaint was received on 7/13/2023 reporting unidentified material noticed on raytecs.The actual sample has not been returned to deroyal for evaluation at this time.A supplier corrective action request (scar) was issued to the raytec supplier meixin medical suzhou co., ltd.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
Unidentified material noticed on raytecs.
Additional Manufacturer Narrative
A complaint was received on 7/13/2023 reporting unidentified material noticed on raytecs.The actual sample was not returned to deroyal for evaluation.A supplier corrective action request (scar) was issued to the raytec supplier meixin medical suzhou co., ltd.The following root cause was determined by the supplier meixin medical suzhou co., ltd: the unidentified material reported by the customer may be the residual cotton seed shells or foreign fibers that were left on the cotton fibers.The workers failed to detect these foreign matters during production, and the contaminated products escaped to the normal line.The following corrective and preventive actions have been taken by meixin medical suzhou co., ltd: notify the raw material supplier of this reported issue.Stress that workers of each production process shall strictly follow the specification procedure.The folding workers shall stop the machine to remove the nonconforming products if detect any foreign matters.The subsequent inspection workers shall inspect carefully to prevent contaminated products escaping to the normal line.Retrain the workers on related operation procedure and quality standard to enhance their quality awareness.Production records were reviewed, and no issues were found.An inventory check of the gauze was made by deroyal, a total of (b)(4) of the 5-19928 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 VASCULAR ACCESS 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
• MDR Report Key: 17390795
• Report Number: 3005011024-2023-00031
• Device Sequence Number: 6742398
• Product Code: LRO
• UDI-Device Identifier: 00749756363495
• UDI-Public: 00749756363495
• 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): 08/09/2023

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: 89-10578
• Device Lot Number: 58774990
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 07/13/2023
• Supplement Date Received by Manufacturer: 07/13/2023
• Initial Report FDA Received Date: 07/25/2023
• Supplement Report FDA Received Date: 08/09/2023
• 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