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

Model Number	VB14116US
Medical Device Problem Code	Device Contamination with Chemical or Other Material (2944)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	06/08/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
No medical records or no medical images have been made available to the manufacturer.As the lot number for the device was provided, a review of the device history records is currently being performed.The device has been returned to the manufacturer for evaluation.The investigation of the reported event is currently underway.The information provided by bard represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bard.
Event or Problem Description
It was reported that upon visual inspection during r&d testing of the device, the device was allegedly observed to have foreign material on the needle tip while the tyvek lid was still intact.There was no patient involvement.
Additional Manufacturer Narrative
Manufacturing review: the device history records have been reviewed and this lot met all release criteria.There was nothing found to indicate there was a manufacturing related cause for this event.This is the only complaint reported to date for this lot number and failure mode.Investigation summary: one vacora needle was returned for evaluation.The vacora needle was examined under magnification, and an unknown substance was noted on the distal tip.The substance was scanned using fourier-transform infrared spectroscopy (ftir), and found to be silicone.The silicone is used and applied to the device during assembly and is not considered foreign material to the device.Therefore, the investigation is unconfirmed for foreign material.Based upon available information, the definitive root cause is determined to be standard device assembly and manufacturing process.The silicone presence meets specification.Labeling review: a review of the product instructions for use (ifu) procedural instructions, indications, warnings, precautions, cautions, possible complications and contraindications showed that the product labeling is adequate.
Event or Problem Description
It was reported that upon visual inspection during r&d testing of the device, the device was allegedly observed to have foreign material on the needle tip while the tyvek lid was still intact.There was no patient involvement.

• 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: 7660670
• Report Number: 2020394-2018-01097
• Device Sequence Number: 134841
• Product Code: KNW
• UDI-Device Identifier: 00801741079351
• UDI-Public: (01)00801741079351
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• PMA/510(K) Number: K082681
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/23/2019

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?: Yes
• Operator of Device: Other
• Device Expiration Date: 01/31/2019
• Device Model Number: VB14116US
• Device Catalogue Number: VB14116US
• Device Lot Number: HUAP0880
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/08/2018
• Initial Date Received by Manufacturer: 06/08/2018
• Supplement Date Received by Manufacturer: 05/20/2019
• Initial Report FDA Received Date: 07/03/2018
• Supplement Report FDA Received Date: 05/23/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1