MAUDE Adverse Event Report: BARD PERIPHERAL VASCULAR, INC. VACORA VACUUM ASSISTED BIOPSY SYS; BIOPSY INSTRUMENT

Model Number	VB10118
Medical Device Problem Code	Mechanical Problem (1384)
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 will be performed.The sample was not returned to the manufacturer for inspection/evaluation.Therefore, the investigation of the reported event is inconclusive.Based upon the available information, the definitive root cause for this event is unknown.The instructions for use (ifu) is adequate for the reported device/patient code(s) and provides general instructions for use, as well as warnings, precautions and potential complications associated with the device.Upon receipt of new or additional information, a follow-up report will be submitted as applicable.
Event or Problem Description
This report summarizes one malfunction events.A review of the events indicated that model vb10118 biopsy instrument allegedly moved unexpectedly.These reports were received from various sources.Of the one events involved patients with no reported patient injury.The patients age and weight not provided.Of the reported patients was female.

• Brand Name: VACORA VACUUM ASSISTED BIOPSY SYS
• Common Device Name: BIOPSY INSTRUMENT
• Manufacturer (Section D): BARD PERIPHERAL VASCULAR, INC.; 1625 w 3rd st.; tempe AZ 85281
• MDR Report Key: 8489069
• Report Number: 2020394-2019-00242
• Device Sequence Number: 19502073
• Product Code: KNW
• UDI-Device Identifier: 00801741079313
• UDI-Public: (01)00801741079313
• 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): 04/05/2019

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?: No
• Operator of Device: No Information
• Device Model Number: VB10118
• Device Catalogue Number: VB10118
• Device Lot Number: UNKNOWN
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/31/2019
• Initial Report FDA Received Date: 04/05/2019
• Patient Sequence Number: 1