MAUDE Adverse Event Report: DEROYAL INDUSTRIES, INC. CMC EXTREMITY PACK; GENERAL SURGICAL SUPPLY PACK, DISPOSABLE

Catalog Number 89-10552.01

Device Problem Break (1069)

Patient Problem Insufficient Information (4580)

Event Date 01/07/2021

Event Type  malfunction  

Event Description

Deroyal extremity pack with contaminant on suction tubing.Entire back table broke down, patient had just entered room and was taken back to pre-op.Explained to patient, surgeon notified.Suction tubing given to quality for follow up.Red substance discovered on outer ridged/textured surface of the suction tubing.

• Brand Name: CMC EXTREMITY PACK
• Type of Device: GENERAL SURGICAL SUPPLY PACK, DISPOSABLE
• Manufacturer (Section D): DEROYAL INDUSTRIES, INC.; 200 debusk lane; powell TN 37849
• MDR Report Key: 11214180
• MDR Text Key: 228206811
• Report Number: 11214180
• Device Sequence Number: 1
• Product Code: KDC
• 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: 01/08/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/22/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 89-10552.01
• Device Lot Number: 53457565
• 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: 01/08/2021
• Event Location: Hospital
• Date Report to Manufacturer: 01/22/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1