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

Model Number	89-10560
Medical Device Problem Code	Material Puncture/Hole (1504)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/26/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A user facility medwatch report (#4900240000-2022-8083) reporting rip in outer blue wrap of pack.Pack removed from room.New pack obtained.A sample was provided to deroyal for evaluation.Root cause: was identified as due to no tray protector being under the basin.Corrective action: quality control specialist contacted tray engineering to evaluate the tray and to add a tray protector under the basin.Engineering change order number 57616 has been created to add a tray protector under the basin.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 5-11976 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.
Event or Problem Description
Rip in outer blue wrap of pack.Pack removed from room.New pack obtained.

• 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: 15276677
• Report Number: 3005011024-2022-00031
• Device Sequence Number: 6439064
• 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): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 08/23/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Model Number: 89-10560
• Device Catalogue Number: 89-10560
• Device Lot Number: 56779199
• 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: 08/23/2022
• 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