Events

Alerte De Sécurité sur DISPOSABLE TECHNICAL NEEDLE FOR ANESTHESIA - Registration: 10033430144, lots: 4222219 and 4217672

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
    809
  • Date
    2005-07-27
  • 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
    The company will arrange for the replacement of the units returned by others in accordance with the characteristic standard of the product. If you have any questions or concerns about this information, please contact your local representative or call the Customer Relationship Center at Tel.0800-555456. ANVISA will be accompanying the actions that will be carried out through the company regarding the whole process of collection and replacement of said product.
  • Cause
    Identification of less than normal luer taper.
  • Action
    Although minor taper does not prevent the use of the product, it should be tightened properly, requiring a 90 ° rotation during the connection between the syringe and the Spinal Needle Cannula. Reviews are being conducted with the mold suppliers to ensure proper preventative maintenance of the molds. Reviews are being conducted with the mold suppliers to ensure the tests performed using the ISO caliber. The areas of Quality Assurance and Projects are developing more sensitive test to detect possible leaks.

Device

DISPOSABLE TECHNICAL NEEDLE FOR ANESTHESIA - Registration: 10033430144, lots: 4222219 and 4217672

Manufacturer

Becton Dickinson Indústrias Cirúrgicas Ltda
  • Source
    ANVSANVISA