Events

Alerte De Sécurité sur Trade Name: Closed System Urine Collection Fellowships Technical Name: Collectors ANVISA Registration Number: 80136990508 Hazard Class: I Model Affected: UREOFIX 500 CLASSIC, EB. 2.0L, TUBE 120CM (4417930) Serial numbers affected: Item 4417930 / lot: 16F01E8SUA.

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
    2118
  • Date
    2016-11-04
  • 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
    Take measures to ensure that the use of the product units belonging to the abovementioned lot is interrupted and segregate the remaining units so that they can be collected by Laboratorios B. Braun SA
  • Cause
    A change in performance of the ureofix 500 classic hourly diurese manifold has been identified. this is due to the possibility of the first compartment of the product emptying its contents before it is completely filled, migrating the urine into the second compartment of this collector. emptying the first compartment makes it difficult to read the patient's diuresis.
  • Action
    Field Action Code AC / 04/2016 triggered under the responsibility of the company Laboratorios B. Braun SA Company will collect for further destruction.

Device

Trade Name: Closed System Urine Collection Fellowships Technical Name: Collectors ANVISA Registra...

Manufacturer

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