Events

Safety Alert for Trade name: BD Eclipse Safety needle / BD Eclipse Hypodermic Needle with Safety Device / BD Eclipse Needle Gasometer Syringe Technical Name: Disposable Needles and Disposable Syringe ANVISA Registration Number: 10033430591/10033430694/10033430689 Hazard Class: II Model Affected : 302811/302812/302813/302814/302815/302816/302817/302818/30281364/364390/364391/365059/365061

According to Agência Nacional de Vigilância Sanitária (ANVISA), this safety alert involved a device in Brazil that was produced by Becton Dickinson Indústrias Cirúrgicas Ltda.

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
  • Event ID
    2066
  • Date
    2017-01-20
  • Event Country
    Brazil
  • Event Source
    ANVISA
  • Event Source URL
    http://www.anvisa.gov.br/sistec/alerta/consultaralerta.asp
  • Notes / Alerts
    Brazilian data is current through June 2018. All of the data comes from Anvisa, 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 Brazil.
  • Extra notes in the data
    BD Brasil will send letters to direct customers (hospitals and laboratories) and distributors who have purchased the affected needles sold since January 2015, reaffirming the need to follow the instructions correctly: In compliance with the strategy adopted by the legal manufacturer (BD EUA) "Center your thumb or index finger on the wider area of ​​the textured digital pad and push the safety device over the needle until you hear or feel it is locked. Visually confirm that the needle is covered. "The product may continue to be used observing the guidelines described in the instructions for use.
  • Reason
    Bd brasil will send letters to direct customers (hospitals and laboratories) and distributors who have purchased the affected needles sold since january 2015, reaffirming the need to follow the instructions correctly: in compliance with the strategy adopted by the legal manufacturer (bd eua) "center your thumb or index finger on the wider area of ​​the textured digital pad and push the safety device over the needle until you hear or feel it is locked. visually confirm that the needle is covered. "the product may continue to be used observing the guidelines described in the instructions for use.
  • Action
    Field Action Code FA 07_Dez17 triggered under the responsibility of the company Becton Dickinson Indústrias Cirúrgicas Ltda. Company will notify the customer.

Device

Trade name: BD Eclipse Safety needle / BD Eclipse Hypodermic Needle with Safety Device / BD Eclip...

Manufacturer

Becton Dickinson Indústrias Cirúrgicas Ltda
  • Source
    ANVSANVISA