MAUDE Adverse Event Report: MERIT MEDICAL SYSTEMS, INC. CORVOCET¿; INSTRUMENT, BIOPSY

Model Number	00884450316672
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/08/2020
Type of Reportable Event	Malfunction
Event or Problem Description
Elderly female with history of left lung nodule.Undergoing procedure for biopsy left lower lobe lung.When the biopsy needle packaging was opened the blunt part of the coaxial was not glued properly to the clear hub.Another needle was opened and use on patient.The defective needle was never used on the patient and no harm was done.

• Brand Name: CORVOCET¿
• Common Device Name: INSTRUMENT, BIOPSY
• Manufacturer (Section D): MERIT MEDICAL SYSTEMS, INC.; 1600 west merit parkway; south jordan UT 84095
• MDR Report Key: 10178373
• Report Number: 10178373
• Device Sequence Number: 16370812
• Product Code: KNW
• UDI-Device Identifier: 00884450316672
• UDI-Public: (01)00884450316672(17)221231(10)H1743882
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 06/11/2020
• Report Date (Section F): 06/11/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 00884450316672
• Device Catalogue Number: CORCA2015B/A
• Device Lot Number: H1743882
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 06/22/2020
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/22/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Weight: 75
• Date Report Sent to FDA: 06/11/2020