Events

Alerte De Sécurité sur 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

Selon Agência Nacional de Vigilância Sanitária (ANVISA), ce/cet/cette alerte de sécurité concerne un dispositif en/au/aux/à Brazil qui a été fabriqué par Becton Dickinson Indústrias Cirúrgicas Ltda.

Qu'est-ce que c'est?

Les alertes fournissent des informations importantes et des recommandations concernant les dispositifs médicaux. Le fait qu'une alerte soit émise ne signifie pas nécessairement qu'un dispositif soit dangereux. Les alertes de sécurité, qui sont envoyées tant aux travailleurs du secteur médical qu'aux utilisateurs de ces dispositifs, peuvent inclure des rappels. Elles peuvent être rédigées par des fabricants mais aussi par des autorités en charge de la santé.

En savoir plus sur les données ici
  • Type d'événement
    Safety alert
  • ID de l'événement
    2066
  • Date
    2017-01-20
  • Pays de l'événement
    Brazil
  • Source de l'événement
    ANVISA
  • URL de la source de l'événement
    http://www.anvisa.gov.br/sistec/alerta/consultaralerta.asp
  • Notes / Alertes
    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.
  • Notes supplémentaires dans les données
    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.
  • Cause
    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