Events

Safety Alert for 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

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
    934
  • Date
    2008-08-20
  • 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 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
  • Reason
    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