MAUDE Adverse Event Report: BARD PERIPHERAL VASCULAR, INC. GHIATAS LOCALIZATION WIRE; BIOPSY INSTRUMENT

Model Number	475201
Medical Device Problem Code	Image Display Error/Artifact (1304)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The lot number for the device was provided and a lot history review will be performed.The sample was not returned to the manufacturer for inspection/evaluation, however, an x-ray was provided for review.The company is still investigating the issue at this time.
Event or Problem Description
This report summarizes one malfunction.A review of the reported information indicated that model 475201 biopsy instrument allegedly experienced artifact from the breast marker was larger in size.This information was received from one source.The malfunction involved patient with no known impact to the patient.Age, sex and weight of the patient were not provided.
Additional Manufacturer Narrative
H10: the lot number for the device was provided and a lot history review was performed.The sample was not returned to the manufacturer for inspection/evaluation; however, images were provided for review.The investigating is confirmed for an artifact.Based upon 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.
Event or Problem Description
This report summarizes one malfunction.A review of the reported information indicated that model 475201 biopsy instrument allegedly experienced artifact from the breast marker was larger in size.This information was received from one source.The malfunction involved patient with no known impact to the patient.Age, sex and weight of the patient were not provided.

• Brand Name: GHIATAS LOCALIZATION WIRE
• Common Device Name: BIOPSY INSTRUMENT
• Manufacturer (Section D): BARD PERIPHERAL VASCULAR, INC.; 1625 w 3rd st.; tempe AZ 85281
• MDR Report Key: 10731359
• Report Number: 2020394-2020-06036
• Device Sequence Number: 3111620
• Product Code: GDF
• UDI-Device Identifier: 00801741079917
• UDI-Public: (01)00801741079917
• 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): 01/05/2021

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: 475201
• Device Catalogue Number: 475201
• Device Lot Number: RECZ0750
• Initial Date Received by Manufacturer: 09/30/2020
• Supplement Date Received by Manufacturer: 12/31/2020
• Initial Report FDA Received Date: 10/23/2020
• Supplement Report FDA Received Date: 01/05/2021
• Patient Sequence Number: 1