MAUDE Adverse Event Report: BARD PERIPHERAL VASCULAR, INC. DISPOSABLE COAXIAL BIOPSY NEEDLE

Catalog Number C2020A

Device Problem Break (1069)

Patient Problem Insufficient Information (4580)

Event Date 11/03/2021

Event Type  malfunction  

Event Description

Biopsy needle broke off at hub inside of patient's lower back.Presence of the needle remnant within the right buttock.This was removed at the time of the procedure.Fda safety report id # (b)(4).

• Brand Name: DISPOSABLE COAXIAL BIOPSY NEEDLE
• Type of Device: BIOPSY NEEDLE
• Manufacturer (Section D): BARD PERIPHERAL VASCULAR, INC.; tempe AZ 85281
• MDR Report Key: 12813644
• MDR Text Key: 280935200
• Report Number: MW5105298
• Device Sequence Number: 1
• Product Code: FCG
• Combination Product (y/n): N
• 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: 11/09/2021

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
• Device Operator: Health Professional
• Device Expiration Date: 02/29/2024
• Device Catalogue Number: C2020A
• Device Lot Number: REFQ3217
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 11/12/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 74 YR
• Patient Sex: Female
• Patient Weight: 141 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White