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

Model Number	477201
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
For five of the six reported malfunctions, the devices have been returned to bd for evaluation and one will not be returned.The company is still investigating the issue at this time.The device is labeled for single use.
Event or Problem Description
This report summarizes six malfunctions.A review of the reported information indicated that model 477201 biopsy instrument allegedly experienced a signal artifact.This information was received from various sources.Of the six malfunctions, one involved a patient with no known impact to the patient and five did not involve a patient.The patients¿ age, weight, and gender were not provided.
Additional Manufacturer Narrative
H10: for five of the six reported malfunctions, lot samples have been returned to bd for evaluation and one was not returned.As lot samples were returned the investigation is inconclusive for the allged signal artifact issue.The root cause was unable to be determined at this time.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 six malfunctions.A review of the reported information indicated that model 477201 biopsy instrument allegedly experienced a signal artifact.This information was received from various sources.Of the six malfunctions, one involved a patient with no known impact to the patient and five did not involve a patient.The patients¿ age, weight, and gender 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: 9198865
• Report Number: 2020394-2019-04016
• Device Sequence Number: 3031057
• Product Code: GDF
• UDI-Device Identifier: 00801741079924
• UDI-Public: (01)00801741079924
• 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): 01/06/2020

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: 477201
• Device Catalogue Number: 477201
• Device Lot Number: REDQ4074, UNKNOWN
• Initial Date Received by Manufacturer: 09/30/2019
• Supplement Date Received by Manufacturer: 12/31/2019
• Initial Report FDA Received Date: 10/16/2019
• Supplement Report FDA Received Date: 01/06/2020
• Patient Sequence Number: 1