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

Model Number	89-10560
Medical Device Problem Code	Contamination /Decontamination Problem (2895)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/12/2021
Type of Reportable Event	Malfunction
Event or Problem Description
A black hair was found on the drape in the (cmc laparotomy pack).
Additional Manufacturer Narrative
A user facility medwatch report ((b)(4)) was received on 01/04/2022 reporting a black hair was found on the drape in the cmc laparotomy pack.A supplier corrective action request (scar) was issued to the drape supplier o & m halyard.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
A black hair was found on the back table cover in the (cmc laparotomy pack).
Additional Manufacturer Narrative
The supplier corrective action request (scar) that was issued to (b)(4) has been canceled.The hair was found on bottom of the drape between the drape and back table cover.The hair sample was returned taped to the back table cover instead of the drape that was first mentioned in the initial report.Quality control has since determined this not to be a vendor issue, due to the hair could have come from somewhere other than the drape.Potential root cause: it was determined by deroyal, but not limited to, 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, and debris contained in vendor supplied items.The following corrective actions have taken place by deroyal: manufacturing personnel were retrained on the dress code procedure (corp.Prc.079) and cleaning procedure (corp.Prc.086), quality control specialist started conducting routine walk-throughs in raw material storage areas to identify any potentially exposed product, manufacturing personnel were instructed to wipe down production lines after every order, supplier corrective action request (scar) was issued to the lab coat supplier, corrective and preventive action point (capa) bp20-21-08-005 has been assigned, and added additional guidance to the manufacturing instructions to indicate that these products have had reports of debris to increase scrutiny during the assembly process.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 LAPAROTOMY 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: 13207442
• Report Number: 3005011024-2022-00001
• Device Sequence Number: 4563952
• Product Code: LRO
• UDI-Device Identifier: 00749756363778
• UDI-Public: 0749756363778
• 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): 01/27/2022

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: 89-10560
• Device Lot Number: 55443917
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/09/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 01/04/2022
• Supplement Date Received by Manufacturer: 01/04/2022
• Initial Report FDA Received Date: 01/10/2022
• Supplement Report FDA Received Date: 01/27/2022
• 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