Events

Alerte De Sécurité sur BD CATETER INTRAVENOUS CENTRAL HYDROCATH AND ACCESSORIES - Record: 10033430196 - Lots: 111121/111405/201348

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
    806
  • Date
    2005-05-13
  • 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
    Due to market decisions, the product BD Catheter Central Intravenous HydrocathTM and Accessories was discontinued in the year 2000. Due to this, the registration was not revalidated with ANVISA, and its expiration in March 2004.
  • Cause
    Bd singapore (manufacturer) received 4 entries that the sealing of the primary packaging (tray versus cap) was incomplete, which could compromise the sterility of the product. it has been reported that bd singapore has not received any reports of increased infection rate related to the use of these products during the last 5 years. however, the evaluation of the manufacturing process identified a failure during packaging and, as a precautionary measure, the manufacturer is collecting all kits that were marketed after 1999, the date the current sealing process was implemented.
  • Action
    No action involving the aforementioned product, since, due to market decisions, the product BD Catheter Central Intravenous HydrocathTM and Accessories had its commercialization interrupted in the year 2000. Due to this the registration was not revalidated with ANVISA, with its maturity in March of 2004. (Registration holder information)

Device

BD CATETER INTRAVENOUS CENTRAL HYDROCATH AND ACCESSORIES - Record: 10033430196 - Lots: 111121/111...

Manufacturer

Becton Dickinson Indústrias Cirúrgicas Ltda
  • Source
    ANVSANVISA