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

Model Number	89-10558
Medical Device Problem Code	Contamination /Decontamination Problem (2895)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/22/2022
Type of Reportable Event	Malfunction
Event or Problem Description
Hair found inside pack on blue wrap.
Additional Manufacturer Narrative
A user facility medwatch report (#4900240000-2022-8084) was received on 8/12/2022 reporting hair found inside pack on blue wrap.The sample has been returned to deroyal for evaluation.Potential root cause: it was determined, 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, natural occurring static, and equipment has loose particulate.The following corrective and or preventive actions have taken place by deroyal: manufacturing personnel were retrained on the dress code procedure (corp.Prc.079) and cleaning procedure (corp.Prc.086), manufacturing personnel were instructed to wipe down production lines after every order, added additional guidance to the manufacturing instructions to indicate that these products have had reports of debris to increase scrutiny during the assembly process, prior to employees entering the manufacturing area they observe each other's lab coats for any foreign matter including hair and lint rollers are being used.Production records were reviewed, and no issues were found.An inventory check of the back table cover was made by deroyal, a total of 50 of the 1261472 back table covers 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: CCASC 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: 15283136
• Report Number: 3005011024-2022-00030
• Device Sequence Number: 7054243
• Product Code: LRO
• UDI-Device Identifier: 00749756364430
• UDI-Public: 00749756364430
• 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): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 08/24/2022

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: 89-10558
• Device Catalogue Number: 89-10558
• Device Lot Number: 57003069
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/19/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/04/2022
• Initial Report FDA Received Date: 08/24/2022
• 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