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

Model Number 89-10581.01

Device Problem Contamination (1120)

Patient Problem Insufficient Information (4580)

Event Date 03/11/2021

Event Type  malfunction  

Event Description

Prior to the patient entering the room, i was alerted by room staff that the vascular pack lot 52995169 was contaminated (brown specks in irrigation bowl).The circulator with the patient were stopped in the hallway and warm blankets were provided to the patient while the or team removed the contaminated items and reopened with a new pack.Doctor was made aware.Pictures were taken of contamination and the brown specks were taped in place in the bowl.The pack was saved and as well as the pack sheet.Our ctl was made aware.We then proceeded to have the same issue with the next 5 packs.#2 vascular pack ref 89-10581.01 lot 53666666 (brown specks in irrigation bowl, #3 laparotomy pack ref 89-10560.01 lot 53634891(black specks on inside of pack), #4 vascular pack ref 89-10581.01 lot 53666666 ( brown on tubing ),#5 laparotomy pack ref 89-10560.01 lot 53634904 ( finger nail looking item) , #6 vascular pack ref 89-10581.01 lot 53450021 (brown specks found on tubing ).All found debris contamination was taped in place where found and pictures were taken.Our final pack was contamination free and the patient was brought into the or.Delay code was documented by circulator and quality will be emailed including pictures.Vascular pack ref 89-10581.01 lot 52995169 (brown specks in bowl).Vascular pack ref 89-10581.01 lot 53666666 (brown specks in bowl).Vascular pack ref 89-10581.01 lot 53666666(brown on suction tubing).Vascular pack ref 89-10581.01 lot 53450021 (brown on tubing).Laparotomy pack ref 89-10560.01 lot 53634891 (black specks on main drape).Laparotomy pack ref 89-10560.01 lot 53634904 (fingernail looking item in bowl).

• Brand Name: DEROYAL
• Type of Device: GENERAL SURGERY TRAY
• Manufacturer (Section D): DEROYAL INDUSTRIES, INC.; 200 debusk lane; powell TN 37849
• MDR Report Key: 11612860
• MDR Text Key: 243774428
• Report Number: 11612860
• 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: 03/16/2021,03/11/2021

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 Operator: Health Professional
• Device Model Number: 89-10581.01
• Device Catalogue Number: 89-10581.01
• Device Lot Number: 52995169
• 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: 03/16/2021
• Event Location: Hospital
• Date Report to Manufacturer: 04/05/2021
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/05/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1