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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEROYAL INDUSTRIES INC. CMC VASCULAR PACK GENERAL SURGERY TRAY

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DEROYAL INDUSTRIES INC. CMC VASCULAR PACK GENERAL SURGERY TRAY Back to Search Results
Model Number 89-10581.01
Device Problems Break (1069); Device Contamination with Chemical or Other Material (2944)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 02/18/2021
Event Type  Malfunction  
Event Description

While opening room for case, after scrub tech scrubbed and started to set up back table, observed short brown hair on back table cover and tape band around lap sponges was broken/torn. Nothing else was touched at the time. Scrub tech has long silver hair and doesn't match found in pack. Pictures of pack were taken and pack was removed from room. Staff obtained another pack and opened it without incident. Did not delay case. Pack was not saved for quality. Pictures of the pack sheet, the back table cover with hair and lap sponges with broken/torn band were obtained and will be sent to quality. Will review with staff to save all packs and cover sheets to send to quality. Pictures x5 attached to report.

 
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Brand NameCMC VASCULAR PACK
Type of DeviceGENERAL SURGERY TRAY
Manufacturer (Section D)
DEROYAL INDUSTRIES INC.
200 debusk lane
powell TN 37849
MDR Report Key11482108
MDR Text Key239794562
Report Number11482108
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 02/23/2021
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received03/15/2021
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL Number89-10581.01
Device Catalogue Number89-10581.01
Device LOT Number53666666
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA02/23/2021
Event Location Hospital
Date Report TO Manufacturer03/15/2021
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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