Events

Alerte De Sécurité sur BD EXACTA - INTRODUCTORY KIT OF ARTERIAPULMONAR CATETER - Registration: 10033430274 - Lots: 309420/406463/311610/311609/311197/406462 /. 311612/309419/309418/380187/406374

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
    807
  • 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
    It is important that the following actions are taken: 1. Identify whether you are using or have stock of the products according to the batches indicated; 2. Discontinue use immediately and block stock; This product will be collected and replaced by your distributor; 3. Complete the Fonnary sent by the company; 4. Return the completed form to the BD, through your distributor or by fax (11) 5185.9642 (BD). If you have any questions or concerns about this information, please contact your local representative or call the Customer Relationship Center at Tel.0800-655654. 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. xxxxx The company informs the closing of the collection process, that is, all existing material in the Brazilian Market was collected and replaced.
  • 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
    BD Singapore is reviewing the sealing process in order to correct the flaw. In the meantime, the visual inspection of 100% of the units was introduced in the manufacturing and packaging process. In Brazil Although no adverse events have been reported with the use of any unit of these batches, BD requests that the use of the product BD EXACTA - CATTERY INTRODUCTOR KIT OF ARTERIAPULMONAR - Registration: 10033430274 - Lots: 309420/406463/311610/311609 / 311197/406462 / 311612/309419/309418/380187/406374 is interrupted and the drives are returned. The company will arrange for the replacement of units returned by others in accordance with the kit's characteristic standard.

Device

BD EXACTA - INTRODUCTORY KIT OF ARTERIAPULMONAR CATETER - Registration: 10033430274 - Lots: 30942...

Manufacturer

Becton Dickinson Indústrias Cirúrgicas Ltda.
  • Source
    ANVSANVISA