Events

Alerte De Sécurité sur BARD TRUGUIDE COAXIAL NEEDLE FOR BIOPSY, model C2016B, registration 80689090075, hazard class II, lots: REWL0924, REXA1695, REXB1529, REXC1632.

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 Bard Brasil Indústria e Comércio de Produtos Médicos Ltda.; Bard Peripheral Vascular, Inc..

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
    1819
  • Date
    2016-02-12
  • 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 potential risk associated with attempting to proceed with coaxial placement, using the sharpened stylus rather than the optional blunt tip stylus, may be variable depending on the anatomical location of the biopsy and may cause an additional unintended risk to tissue, vessels and other organs. ### UPDATED ON 10/26/2017, the company presented the completion report of the field action proving the sending of the security warning to the client with evidence of science and all actions completed.
  • Cause
    The coaxial biopsy needle may inadvertently have a blunt-tipped stylet of incorrect size that will not pass through the coaxial. specifically the product should contain a blunt tip stylus of 19 gauge and actually contains a 17 gauge stylus.
  • Action
    Gathering and destruction. Evaluate inventory and do not use or distribute any affected product. If the affected product has been safely used, no further action is required.

Device

BARD TRUGUIDE COAXIAL NEEDLE FOR BIOPSY, model C2016B, registration 80689090075, hazard class II,...

Manufacturer

Bard Brasil Indústria e Comércio de Produtos Médicos Ltda.; Bard Peripheral Vascular, Inc.