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

Model Number	89-10543
Medical Device Problem Code	Contamination /Decontamination Problem (2895)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/06/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A user facility medwatch report (#(b)(4)) was received on 3/31/2023 reporting hair found in towels of sterile pack.A supplier corrective action request (scar) was issued to the towel supplier meixin medical.The actual sample was not available to be returned to deroyal for evaluation.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
Hair found in towels of sterile pack.
Additional Manufacturer Narrative
A user facility medwatch report (#(b)(4)) was received on 3/31/2023 reporting hair found in towels of sterile pack.The actual sample was not available to be returned to deroyal for evaluation.A supplier corrective action request (scar) was issued to the towel supplier meixin medical.The following root cause was determined by the supplier meixin medical: the packaging workers may have tidied up their working clothes within the work area or they may not be wearing their working clothes properly, so the hair and debris could fall onto the product from their bodies.The subsequent inspecting workers didn't detect the hair and the hair-contaminated products escape to the normal line.The following corrective and preventive actions have been taken by meixin medical: stressed to the workers to wear their working clothes properly per standard requirement, and whenever they need to tidy up or correct the wearing of their working clothes, they should do it in the changing room instead of the working area.Stressed to the subsequent inspecting workers that they should check the product according to procedure requirements, and to pick out the nonconforming product immediately once found.Production records were reviewed, and no issues were found.An inventory check of the towels was made by deroyal, a total of 32 of the 5-5042 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: CARDIAC LINEN 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: 16682352
• Report Number: 3005011024-2023-00020
• Device Sequence Number: 15473709
• Product Code: LRO
• UDI-Device Identifier: 00749756363525
• UDI-Public: 00749756363525
• 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): 04/26/2023

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: 89-10543
• Device Catalogue Number: 89-10543
• Device Lot Number: 58214669
• 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: 03/31/2023
• Supplement Date Received by Manufacturer: 03/31/2023
• Initial Report FDA Received Date: 04/05/2023
• Supplement Report FDA Received Date: 04/26/2023
• 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