MAUDE Adverse Event Report: DEROYAL INDUSTRIES, INC. DEROYAL; GENERAL SURGERY TRAY

Model Number 89-10581.01

Device Problem Break (1069)

Patient Problem Insufficient Information (4580)

Event Date 04/06/2021

Event Type  malfunction  

Event Description

A cmc vascular pack from deroyal was opened that contained a pack of lap sponges with the tape broken.The laps were removed from the field before the patient was brought into the room.The remainder of the pack/contents were used for procedure.Laps with broken band not saved; no pictures taken.Packing list saved.

• Brand Name: DEROYAL
• Type of Device: GENERAL SURGERY TRAY
• Manufacturer (Section D): DEROYAL INDUSTRIES, INC.; 200 debusk lane; powell TN 37849
• MDR Report Key: 11715647
• MDR Text Key: 246988144
• Report Number: 11715647
• Device Sequence Number: 1
• Product Code: LRO
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 04/14/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/23/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 89-10581.01
• Device Catalogue Number: 89-10581.01
• Device Lot Number: 53850236
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 04/14/2021
• Event Location: Hospital
• Date Report to Manufacturer: 04/23/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1