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

Model Number	475201
Medical Device Problem Code	Signal Artifact/Noise (1036)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The lot number was provided; therefore, a lot history review was performed.The sample was not returned to bd for evaluation but two x-rays were returned for review.The investigation was confirmed for the reported signal artifact.Based on the information provided the definitive root cause is unknown.The device is labeled for single use.
Event or Problem Description
This report summarizes one malfunction.A review of the reported information indicates that model 475201 biopsy instrument experienced a signal artifact.The information was received from a single source.The malfunction involved a patient with no reported patient injury.The (b)(6) year old female patient weighed (b)(6) lbs.
Additional Manufacturer Narrative
H10: the initial mdr submitted for this malfunction inaccurately reported the mdr date of awareness.The correct mdr date of awareness is (b)(6) 2020.H10: the lot number was provided; therefore, a lot history review was performed.The sample was not returned to bd for evaluation but two x-rays were returned for review.The investigation was confirmed for the reported signal artifact.Based on the information provided the definitive root cause 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 indicates that model 475201 biopsy instrument experienced a signal artifact.The information was received from a single source.The malfunction involved a patient with no reported patient injury.The 46 year old female patient weighed 113 lbs.

• 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: 9944298
• Report Number: 2020394-2020-02582
• Device Sequence Number: 10929175
• 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): 04/21/2020

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: 475201
• Device Catalogue Number: 475201
• Device Lot Number: REDQ0895
• Initial Date Received by Manufacturer: 04/01/2020
• Supplement Date Received by Manufacturer: 04/21/2020
• Initial Report FDA Received Date: 04/09/2020
• Supplement Report FDA Received Date: 04/21/2020
• Patient Sequence Number: 1