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

Model Number 89-10560

Device Problem Contamination /Decontamination Problem (2895)

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

Event Date 05/27/2021

Event Type  malfunction  

Event Description

A laparotomy pack was opened and was noted to have some black debris in it.The patient was not in the room.The contaminated pack was removed and replaced with a new pack prior to the patient entering the room.I have a basin with some of that black debris taped to it that i can turn into the quality department along with the sheet from the pack, but it was a laparotomy pack lot number 54368290 expiration was 9/1/2022.

• Brand Name: DEROYAL
• Type of Device: GENERAL SURGERY TRAY
• Manufacturer (Section D): DEROYAL INDUSTRIES, INC.; 200 debusk lane; powell TN 37849
• MDR Report Key: 12031665
• MDR Text Key: 257179934
• Report Number: 12031665
• 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: 06/02/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/21/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 89-10560
• Device Catalogue Number: 89-10560
• Device Lot Number: 54368290
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 06/02/2021
• Event Location: Hospital
• Date Report to Manufacturer: 06/21/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1