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

Model Number	00884450476390
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/10/2022
Type of Reportable Event	Malfunction
Event or Problem Description
Upon inspecting the biopsy needle for procedure, the physician discovered that the coaxial was not glued properly and would not stay attached to the hub.It was not used on a patient.Manufacturer response for instrument, biopsy, corvocet¿ (per site reporter): will investigate.

• 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: 13756922
• Report Number: 13756922
• Device Sequence Number: 16736580
• Product Code: KNW
• UDI-Device Identifier: 00884450476390
• UDI-Public: (01)00884450476390(17)240930(10)12281931(01)00884450476390
• 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): 03/10/2022
• Report Date (Section F): 03/10/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 00884450476390
• Device Catalogue Number: CORCA1815B/B
• Device Lot Number: 12281931
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 03/14/2022
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/14/2022
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown
• Date Report Sent to FDA: 03/10/2022