Device product
Bard Marquee Disposable Core Biopsy Instrument Kit, REF: MQK2016
Z-0027-2024
Product summary
- Event
- Event 92994
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 1,545
- Official record key
device-enforcement:Z-0027-2024
Official wording
Reason: Diameter mismatch between coaxial and biopsy needle (cutting cannula) in disposable core biopsy instrument kits, where the coaxial cannula inner diameter prohibits the biopsy needle (cutting cannula) from properly fitting into the coaxial cannula and accessing target tissue, which may lead to repeated procedure, and procedural complications, such as pain/discomfort, pneumothorax, and bleeding.
Code information: UDI-DI: 00801741097393, Lot: 0001480774, Exp: 07/28/2025
Distribution pattern: Worldwide - US Nationwide distribution in the states of PR, CO, TX, CA, WA, OR, AZ, NJ, NY, OH, NC, MD, MI, LA, IN, AK, TN and the countries of CA, AU, BE.
Derived failure modes
-
Unknown
Diameter mismatch between coaxial and biopsy needle (cutting cannula) in disposable core biopsy instrument kits, where the coaxial cannula inner diameter prohibits the biopsy needle (cutting cannula) from properly fitting into the coaxial cannula and accessing target tissue, which may lead to repeated procedure, and procedural complications, such as pain/discomfort, pneumothorax, and bleeding.