Events

Safety Alert for TruGuide Disposable Coaxial Biopsy Needles

According to Department of Health, this safety alert involved a device in Hong Kong that was produced by Bard Peripheral Vascular.

What is this?

Alerts provide important information and recommendations about products. Even though an alert has been issued, it does not necessarily mean a product is considered to be unsafe. Safety Alerts, addressed to health workers and users, may include recalls. They can be written by manufacturers, but also by health officials.

Learn more about the data here
  • Type of Event
    Safety alert
  • Date
    2016-02-15
  • Event Date Posted
    2016-02-15
  • Event Country
    Hong Kong
  • Event Source
    DH
  • Event Source URL
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20160215.html
  • Notes / Alerts
    Hong Kong data is current through September 2018. All of the data comes from the Department of Health (Hong Kong), except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Hong Kong.
  • Extra notes in the data
    Medical Device Safety Alert
  • Reason
    Medical device safety alert: bard truguide disposable coaxial biopsy needles medical device manufacturer, bard peripheral vascular, inc., has issued a medical device safety alert concerning its bard truguide disposable coaxial biopsy needles [part number: c2016b, lot numbers: rewl0924, rexa1695, rexb1529, rexc1632]. the manufacturer has confirmed that the product code/ lot number combination listed above may be at risk of having an incorrectly sized blunt tip stylet within its packaging that will not pass through the coaxial. specifically, the product should contain a 19 gauge blunt tip stylet when the actual packaged product contains a 17 gauge blunt tip stylet. according to the manufacturer, the potential hazard associated with attempting to proceed in the placement of the coaxial utilising the sharp trocar stylet, instead of the intended optional blunt tip stylet, may be variable depending on the anatomical location of the biopsy and may pose an incremental risk of unintended injury to tissue, vasculature, or other organs. if the affected device has already been safely used, then no further product related action is required. product recall is on-going. according to the local supplier, the affected products are not distributed in hong kong. if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 15 february 2016.

Device

TruGuide Disposable Coaxial Biopsy Needles
  • Model / Serial
  • Product Description
    Medical Device Safety Alert: Bard TruGuide Disposable Coaxial Biopsy Needles
  • Manufacturer
    Bard Peripheral Vascular

Manufacturer

Bard Peripheral Vascular