MAUDE Adverse Event Report: BARD PERIPHERAL VASCULAR INC. 18X16 BARD MISSION DISPOSABLE CORE BIOPSY INSTRUMENT KIT; INSTRUMENT, BIOPSY

Device Problems Break (1069); Detachment of Device or Device Component (2907)

Patient Problem Foreign Body In Patient (2687)

Event Date 11/14/2022

Event Type  Injury  

Event Description

Biopsy resulted in equipment failure of broken needle (part of trochar) in lung.Surgical removal of foreign body, patient admitted for observation.Due to issues with reporting online, this form is being completed and submitted.

• Brand Name: 18X16 BARD MISSION DISPOSABLE CORE BIOPSY INSTRUMENT KIT
• Type of Device: INSTRUMENT, BIOPSY
• Manufacturer (Section D): BARD PERIPHERAL VASCULAR INC.; tempe AZ 85281
• MDR Report Key: 16313091
• MDR Text Key: 309091800
• Report Number: MW5114751
• Device Sequence Number: 1
• Product Code: KNW
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Unknown
• Type of Report: Initial
• Report Date: 01/31/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/06/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention; Hospitalization
• Patient Age: 64 YR
• Patient Sex: Female