MAUDE Adverse Event Report: BARD PERIPHERAL VASCULAR, INC. BARD BIOPSY BREAST TISSUE MARKER; MARKER, RADIOGRAPHIC, IMPLANTABLE

Model Number SMUC10R

Device Problem Activation, Positioning or Separation Problem (2906)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 04/29/2021

Event Type  malfunction  

Event Description

Breast biopsy completed with attempted clip placement.The bard biopsy clip failed to deploy.Fda safety report id# (b)(4).

• Brand Name: BARD BIOPSY BREAST TISSUE MARKER
• Type of Device: MARKER, RADIOGRAPHIC, IMPLANTABLE
• Manufacturer (Section D): BARD PERIPHERAL VASCULAR, INC. ; franklin lakes NJ 07417 1880
• MDR Report Key: 11769120
• MDR Text Key: 249024304
• Report Number: MW5101138
• Device Sequence Number: 1
• Product Code: NEU
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 04/30/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/03/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: SMUC10R
• Device Catalogue Number: SMUC10R
• Device Lot Number: VTEZ00642
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1