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

Catalog Number 89-10560.01

Device Problem Device Contamination with Chemical or Other Material (2944)

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

Event Date 02/10/2021

Event Type  malfunction  

Event Description

After opening the deroyal laparotomy pack # 89-10560.01, lot # 53311718, exp 01/09/2022.It was observed that there was brownish dried betadine looking "smudges" on the items in the large blue basin.This was the only location of the brown substance.Picture was taken of asepto and submitted to quality.Blue basin and items in basin were thrown away-staff stated that it was 'nasty".Packed list saved.Picture of pack list sent to quality.Opened individual sterile items that had been thrown away with the blue bin for the case.This did not delay the case.Reminded staff that in the future, please do not throw away items, but save them so that we can submit to quality.Pictures of packing list and asepto attached to report.

• Brand Name: DEROYAL
• Type of Device: GENERAL SURGERY TRAY
• Manufacturer (Section D): DEROYAL INDUSTRIES, INC.; 200 debusk lane; powell TN 37849
• MDR Report Key: 11444674
• MDR Text Key: 238627081
• Report Number: 11444674
• 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: 02/10/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/09/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 89-10560.01
• Device Lot Number: 53311718
• 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: 02/10/2021
• Event Location: Hospital
• Date Report to Manufacturer: 03/09/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 16425 DA
• Patient Weight: 96