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U.S. Department of Health and Human Services

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

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DEROYAL INDUSTRIES, INC. DEROYAL GENERAL SURGERY TRAY Back to Search Results
Catalog Number 89-10560.01
Device Problem Contamination /Decontamination Problem (2895)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 04/09/2021
Event Type  Malfunction  
Event Description

On opening for the case, deroyal laparotomy pack was opened and dark specks were found in the large blue basin. Pack handed off, blue basin and bowl with specks taped in it, and pack sheet taken to quality. Staff opened 2nd deroyal laparotomy pack ref 89-10560. 01 lot 53634912 exp 1/10/22 and there were black specks and white string in large blue basin. Items taped in basin, basin and pack sheet were saved and taken to quality. Staff picked new single supplies for case. Caused minimal delay-approx. 5 mins. , patient not in room at time. Basins x2 with debris taped to inside of basins saved with associated packing lists.

 
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Brand NameDEROYAL
Type of DeviceGENERAL SURGERY TRAY
Manufacturer (Section D)
DEROYAL INDUSTRIES, INC.
200 debusk lane
powell TN 37849
MDR Report Key11752268
MDR Text Key248180017
Report Number11752268
Device Sequence Number1
Product Code LRO
Combination Product (Y/N)N
Number of Events Reported1
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
0 PatientS WERE Involved in the Event:
Date FDA Received04/30/2021
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device Catalogue Number89-10560.01
Device LOT Number53634912
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer04/15/2021
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA04/14/2021
Event Location Hospital
Date Report TO Manufacturer04/30/2021
Was Device Evaluated By Manufacturer? No Answer Provided
Is The Device Single Use? No Answer Provided
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

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