Events

Alerte De Sécurité sur OffRoad - Reintroduction Catheter - Record 10341350691 - Hazard Class II (Medium risk) - Technical Name: Catheters - Model H74939202100540 - Affected lots 16514006 (SCHEDULE OF DISTRIBUTION IN ANNEX)

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 Boston Scientific do Brasil Ltda.; Boston Scientific Clonmel Limited.

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
    1425
  • Date
    2014-09-18
  • 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
    According to the company, "affected lots do not have the potential of associated risks, because they are currently valid, without any risk to the patient, so there are no consequences of using these lots."
  • Cause
    The product of offroad reintroduction catheter is composed of two components, contained in an external cardboard box: the balloon catheter of posiconamento and the lancet of the microcatheter. the company has identified that the outer carton contains a validity period of two months beyond the actual expiration date. however, the actual expiration date of each of the components is presented correctly in their individual inner packages.
  • Action
    The company decided to collect the affected products - Pickup for return to the manufacturer. - Offroad Code 01-2014. (LETTER OF NOTIFICATION TO THE CLIENT IN ANNEX).

Device

OffRoad - Reintroduction Catheter - Record 10341350691 - Hazard Class II (Medium risk) - Technica...

Manufacturer

Boston Scientific do Brasil Ltda.; Boston Scientific Clonmel Limited
  • Société-mère du fabricant (2017)
    Boston Scientific
  • Commentaire du fabricant
    “We take a patient-first approach to assessing the applicability of every recall and communicate to regulatory bodies in all geographies where the recalled device is sold,” Boston Scientific said in a statement to ICIJ. “We have coordinated several recalls across many countries in a timely manner,” the company said, adding that it complies with all national laws, which can often vary and require different processes for reporting information or taking action on recalls. The company said it uses a rigorous and uniform process to take action on recalls and that “when we initiate a field action (e.g. recall, safety alert), every customer who has received an affected product receives a communication that includes a letter for the physician.”
  • Source
    ANVSANVISA