Events

Alerte De Sécurité sur STERILE DISCHARGEABLE SYRINGE WITHOUT NEEDLE 60 ML. Reg. ANVISA: 10033430371. Catalog Number: 309653. Lots Affected: Check the list available at http://www.anvisa.gov.br/tecnovigilancia/alertas/anexos_2008/alerta_934_Lotes_Afetados.pdf

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
    934
  • Date
    2008-08-20
  • 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 Ltda has decided to take a corrective action due to the observation that, at low atmospheric pressures (observed at altitudes above 2,438 meters), the syringe packaging of the aforementioned lots can open and cause contamination of the product. According to the company, there was no market complaint regarding problems with the integrity of the sealing of the unit packaging of the product. To access the company's communication letter, access the electronic address: http://www.anvisa.gov.br/tecnovigilancia/alertas/anexos_2008/alerta_934_carta_Comunicacao_Clientes.pdf
  • Cause
    Commitment of the integrity of the sealing of the unit syringe package.
  • Action
    As a precautionary measure BD Ltda started a field action to collect the lots under risk in Brazil, sending letters of communication to all customers affected by this problem. The immediate action of the customers is to immediately discontinue the use of the lots mentioned, segregating them and identifying them immediately so that they are not inadvertently used.

Device

STERILE DISCHARGEABLE SYRINGE WITHOUT NEEDLE 60 ML. Reg. ANVISA: 10033430371. Catalog Number: 309...

Manufacturer

Becton Dickinson Indústrias Cirúrgicas Ltda.
  • Source
    ANVSANVISA