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

Model Number	479201
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 for the one malfunction; therefore, a lot history review is currently being performed.The device was returned for evaluation and the company is still investigating the issue at this time.
Event or Problem Description
This report summarizes the one malfunction.A review of the reported information indicated that model 479201 breast localization wire allegedly experienced signal artifact.This information was received from one source.Of the one signal artifact, one involved a patient with no patient consequences.The patient information was not provided.
Additional Manufacturer Narrative
H10: the lot number was provided for the malfunction, and a lot history review was performed.The sample was returned for evaluation and images were provided for review.The company is still investigating the issue at this time.The device was labeled for single use.H10: g4 h11: b5 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 the one malfunction.A review of the reported information indicated that model 479201 breast localization wire allegedly experienced signal artifact.This information was received from one source.This malfunction involved a patient with no consequences.The patient's age, weight, and gender were not provided.
Event or Problem Description
This report summarizes the one malfunction.A review of the reported information indicated that model 479201 breast localization wire allegedly experienced signal artifact.This information was received from one source.This malfunction involved a patient with no consequences.The patient's age, weight, and gender were not provided.
Additional Manufacturer Narrative
H10: the lot number was provided for the malfunction, and a lot history review was performed.The sample was returned for evaluation and images were provided for review.Based on the image review, the investigation is confirmed for the reported imaging artifact.Based upon the available information, the definitive root cause for this event is unknown.The device was 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: GHIATAS LOCALIZATION WIRE
• Common Device Name: BREAST LOCALIZATION WIRE
• Manufacturer (Section D): BARD PERIPHERAL VASCULAR, INC.; 1625 w 3rd st.; tempe AZ 85281
• MDR Report Key: 9607032
• Report Number: 2020394-2020-00655
• Device Sequence Number: 585031
• Product Code: GDF
• UDI-Device Identifier: 00801741079931
• UDI-Public: (01)00801741079931
• 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,Followup
• Report Date (Section B): 07/09/2020

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: 479201
• Device Catalogue Number: 479201
• Device Lot Number: REBW1089
• Initial Date Received by Manufacturer: 12/31/2019
• Supplement Date Received by Manufacturer: 03/31/2020; 06/26/2020
• Initial Report FDA Received Date: 01/20/2020
• Supplement Report FDA Received Date: 04/21/2020; 07/09/2020
• Patient Sequence Number: 1