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

Model Number 89-10560

Device Problem Material Puncture/Hole (1504)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 05/26/2022

Event Type  malfunction  

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 Description

Rip in outer blue wrap of pack.Pack removed from room.New pack obtained.

• Brand Name: CMC LAPAROTOMY PACK
• Type of Device: 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
• MDR Text Key: 305168103
• Report Number: 3005011024-2022-00031
• Device Sequence Number: 1
• Product Code: LRO
• UDI-Device Identifier: 00749756363778
• UDI-Public: 00749756363778
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K842648
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 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
• Initial Date Manufacturer Received: 08/04/2022
• Initial Date FDA Received: 08/23/2022
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1