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	01/06/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A complaint was received on 1/6/2023 reporting hair in paper towel.A supplier corrective action request (scar) was issued to the paper towel supplier (b)(4).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
Hair in paper towel.
Additional Manufacturer Narrative
A complaint was received on 1/6/2023 reporting hair in paper towel.The sample was returned to deroyal for evaluation and only the lot number was provided to o&m halyard, inc.A supplier corrective action request (scar) was issued to the paper towel supplier o&m halyard, inc.The true root cause was unable to be determined by the supplier o&m halyard, inc.A review of the device history record was performed and confirmed that the lot was manufactured according to specifications.The following corrective and preventive actions have been taken by drape supplier o&m halyard, inc.Perform mid-year annually quality reinforcement on ja-08365 for good manufacturing practices.Notification of this reported incident was sent to the manufacturing area to bring awareness of the issue reported.Complaint data is continuously monitored to identify upward trends associated with the reported incident.Production records were reviewed, and no issues were found.An inventory check of the paper towel was made by deroyal, a total of (b)(4) of the 1180883 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 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: 16131100
• Report Number: 3005011024-2023-00002
• Device Sequence Number: 18023610
• Product Code: LRO
• UDI-Device Identifier: 00749756363778
• UDI-Public: 00749756363778
• 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): 04/19/2023

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: 89-10560
• Device Catalogue Number: 89-10560
• Device Lot Number: 58178127
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/06/2023
• Supplement Date Received by Manufacturer: 01/06/2023
• Initial Report FDA Received Date: 01/10/2023
• Supplement Report FDA Received Date: 04/19/2023
• 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