MAUDE Adverse Event Report: BARD PERIPHERAL VASCULAR, INC. SENOMARK MARKER; BREAST TISSUE MARKER

Model Number	SMEC10GSS
Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Event or Problem Description
This report summarizes one malfunction event.A review of the events indicated that model smec10gss marker allegedly experienced patient-device incompatibility.This report was received from one sources.The device was used in the patient, a (b)(6) year-old female, of (b)(6) lbs.There was no reported patient injury.

• Brand Name: SENOMARK MARKER
• Common Device Name: BREAST TISSUE MARKER
• Manufacturer (Section D): BARD PERIPHERAL VASCULAR, INC.; 1625 w 3rd st.; tempe AZ 85281
• MDR Report Key: 8525439
• Report Number: 2020394-2019-00480
• Device Sequence Number: 13920899
• Product Code: NEU
• UDI-Device Identifier: 00801741031915
• UDI-Public: (01)00801741031915
• 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
• Report Date (Section B): 04/17/2019

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: SMEC10GSS
• Device Catalogue Number: SMEC10GSS
• Device Lot Number: VTCU00317
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/31/2019
• Initial Report FDA Received Date: 04/17/2019
• Patient Sequence Number: 1