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

Model Number 89-10540

Device Problem Material Puncture/Hole (1504)

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

Event Date 06/15/2022

Event Type  malfunction  

Event Description

Outer drape from deroyal cmc carotid pack arrived with hole in drape.Outer plastic packaging not affected therefore hole occurred during manufacturing.

Manufacturer Narrative

A user facility medwatch report (#4900240000-2022-8056) was received on 06/15/2022 reporting outer drape from deroyal cmc carotid pack arrived with hole in drape.Outer plastic packaging not affected therefore hole occurred during manufacturing.A photo of the hole in outer blue drape was provided to deroyal for evaluation.Potential root cause: it is possible that it may be the placement of the graduate pitcher handle.The placement of the graduate pitcher handle needs to be turned different inside the tray, to prevent holes in the back table cover.Corrective action: quality control specialist contacted tray engineering to evaluate the tray for a placement change on the graduate with handle.With emphasis on the way the handle is turned inside the tray to prevent holes in the back table cover.Engineering change order number 57312 has been created to update the routing on the graduate.An inventory check was made by deroyal, a total of 25 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: CMC CAROTID 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: 14850310
• MDR Text Key: 303269485
• Report Number: 3005011024-2022-00025
• Device Sequence Number: 1
• Product Code: LRO
• UDI-Device Identifier: 00749756364454
• UDI-Public: 00749756364454
• 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: 06/29/2022

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: 89-10540
• Device Catalogue Number: 89-10540
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/27/2022
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/15/2022
• Initial Date FDA Received: 06/29/2022
• 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