Events

Alerte De Sécurité sur Spinocath - Spinal Anesthesia Kit Technical Name: Anesthesia Kit ANVISA Registration Number: 10008530204 Hazard Class: II Affected Model: 4517725 Serial numbers Affected: lot: 2I20018501

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 Laboratórios B. Braun S.A.; B. Braun Melsungen AG.

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
    2119
  • Date
    2016-09-20
  • 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
    Interruption of the use of said lot, segregation thereof, information to B. Braun SA Laboratories of the quantities of existing units of this batch number for collection.
  • Cause
    It was identified the possibility of holes in the pvc film, responsible for performing a sterile barrier to the product spinocath g22. this type of orifice was verified in pvc film with thermoforming measuring 25mm. it is important to note that laboratorios b. braun sa canceled the registration of the item in question in 2014. however, it was identified the sale of 40 units of lot 2i20018501, (manufactured on 09/20/2012 and dated maturity for 09/2017) to a single customer, who had, in the year 2012, a relationship as distributor of products of b. braun sa.
  • Action
    Field Action Code AC / 02/2016 triggered under the responsibility of the company Laboratorios B. Braun SA Company will collect for further destruction.

Device

Spinocath - Spinal Anesthesia Kit Technical Name: Anesthesia Kit ANVISA Registration Number: 1000...

Manufacturer

Laboratórios B. Braun S.A.; B. Braun Melsungen AG