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

Model Number	VB10118US
Medical Device Problem Codes	Failure to Calibrate (2440); Device Contamination with Chemical or Other Material (2944)
Health Effect - Clinical Code	No Patient Involvement (2645)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
As the lot number for the device was not provided, a lot history review was not performed.The sample was returned to the manufacturer for inspection/evaluation.Plastic fibers on the returned device was identified.Based on 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 vb10118us biopsy instrument allegedly failed to calibrate and experienced device contamination.This information was received from one source.The one reported malfunction did not involve a patient.The age and weight of the female patient was not provided.
Event or Problem Description
This report summarizes one malfunction.A review of the reported information indicated that model vb10118us biopsy instrument allegedly failed to calibrate.This information was received from one source.The one reported malfunction did not involve a patient.The age and weight of the female patient was not provided.
Additional Manufacturer Narrative
H10: as the lot number for the device was not provided, a lot history review could not be performed.The device was returned to the manufacturer for evaluation.Therefore, the investigation is unconfirmed for the reported failure to calibrate.Based on the available information, the definitive root cause for this event is unknown.The device is labeled for single use.H11:section a through f - the information provided by bd 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 bd.

• 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: 10722924
• Report Number: 2020394-2020-06007
• Device Sequence Number: 1191823
• Product Code: KNW
• UDI-Device Identifier: 00801741079320
• UDI-Public: (01)00801741079320
• 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,Followup
• Report Date (Section B): 01/07/2021

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: VB10118US
• Device Catalogue Number: VB10118US
• Device Lot Number: UNKNOWN
• Initial Date Received by Manufacturer: 09/30/2020
• Supplement Date Received by Manufacturer: 12/31/2020
• Initial Report FDA Received Date: 10/22/2020
• Supplement Report FDA Received Date: 01/07/2021
• Patient Sequence Number: 1