MAUDE Adverse Event Report: BARD PERIPHERAL VASCULAR, INC. VACORA NEEDLE; BIOPSY INSTRUMENT

Model Number	VB14116US
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
As the lot number for the device was provided, a manufacturing review was performed.The sample was returned to the manufacturer for inspection.No functional testing was not performed due to the returned sample condition.Therefore the investigation is inconclusive for the alleged malfunction.Based upon the available information, the definitive root cause for this event is unknown.The device is labeled for single use.
Event or Problem Description
This report summarizes one malfunction.A review of the reported information indicated that model vb14116us biopsy instrument allegedly experienced tube detachment.This information was received from one source.The alleged malfunction involved a patient with no consequences.The age and weight of the female patient was not provided.

• Brand Name: VACORA NEEDLE
• Common Device Name: BIOPSY INSTRUMENT
• Manufacturer (Section D): BARD PERIPHERAL VASCULAR, INC.; 1625 w 3rd st.; tempe AZ 85281
• MDR Report Key: 10283226
• Report Number: 2020394-2020-04499
• Device Sequence Number: 16860012
• Product Code: KNW
• UDI-Device Identifier: 00801741079351
• UDI-Public: (01)00801741079351
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 07/16/2020

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: No Information
• Device Model Number: VB14116US
• Device Catalogue Number: VB14116US
• Device Lot Number: HUBT0159
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/30/2020
• Initial Report FDA Received Date: 07/16/2020
• Patient Sequence Number: 1