MAUDE Adverse Event Report: BARD PERIPHERAL VASCULAR INC BARD MISSION DISPOSABLE CORE BIOPSY INSTRUMENT KIT; INSTRUMENT, BIOPSY

Model Number	2020MSK
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	08/03/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
During ct guided biopsy of lung, biopsy needed broke on retrieval resulting in 12cm of needle being retained and requiring surgery to remove.Fda safety report id # (b)(4).

• Brand Name: BARD MISSION DISPOSABLE CORE BIOPSY INSTRUMENT KIT
• Common Device Name: INSTRUMENT, BIOPSY
• Manufacturer (Section D): BARD PERIPHERAL VASCULAR INC; tempe AZ 85281
• MDR Report Key: 12342687
• Report Number: MW5103337
• Device Sequence Number: 17059157
• Product Code: KNW
• UDI-Device Identifier: 00801741097102
• UDI-Public: (01)00801741097102
• Initial Reporter State: TX
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Voluntary
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 08/16/2021

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
• Operator of Device: Health Professional
• Device Expiration Date: 06/28/2023
• Device Model Number: 2020MSK
• Device Catalogue Number: 2020MSK
• Device Lot Number: 0001373696
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/18/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 34 YR