Alerta De Seguridad para BD Vacutainer Glass Tubes with Vacuum Blood Collection Reagents Technical Name: BOTTLE OR MATERIAL FOR COLLECTION, STORAGE OR TRANSPORTATION OF BIOLOGICAL SAMPLES ANVISA Registration Number: 10033430467 Hazard Class: I Affected Model: VACUTAINER TUBE CITRATE .105 M TAMPA HEMOGARD 4.5 ML Serial numbers affected: Lots: 5336909; 5357632; 6,040,953; 6064634; 6124932; 6173983; 6187600

Según Agência Nacional de Vigilância Sanitária (ANVISA), este evento ( alerta de seguridad ) involucró a un dispositivo médico en Brazil que fue producido por Becton Dickinson Indústrias Cirúrgicas Ltda.; BECTON DICKINSON AND COMPANY.

¿Qué es esto?

Las alertas proporcionan información importante y recomendaciones sobre los productos. Aunque se haya emitido una alerta, esto no significa necesariamente que el producto se considera peligroso. Las alertas de seguridad, dirigidas a trabajadores de la salud y a usuarios, pueden incluir retiro de equipos. Pueden ser escritas por los fabricantes, pero también por funcionarios del área de salud.

Más información acerca de la data acá
  • Tipo de evento
    Safety alert
  • ID del evento
  • Fecha
  • País del evento
  • Fuente del evento
  • URL de la fuente del evento
  • Notas / Alertas
    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.
  • Notas adicionales en la data
    The letter was forwarded to customers who purchased the affected lots and advises users to: "Be sure to use Personal Protective Equipment (EPI) in accordance with instructions for use of the product, such as protective gloves and waterproof clothing, during and after The collection of any additional equipment required to ensure a safe collection, such as protective masks, should be considered; It is recommended to hold the tube while it is in the holder during collection. blood with BD Vacutainer® Push Button or BD Vacutainer® Safety-Lok ™ venipuncture safety device, the tube must be held while it is in the holder and held with the cap positioned up until the blood collection is completed. In addition, BD provided free letter service on 0800 055 5654 and e-mail in order to clarify any possible doubts to its customers.
  • Causa
    The bd identified an increase in the number of reports related to the occurrence of cap loosening during collection in some specific batches of vacutainer® citrate 0.0105m tubes hemogard ™ cap 4.5 ml. in this type of occurrence, the cap may remain attached to the distal needle at the disconnection of the tube at the end of the collection procedure.
  • Acción
    Field Action Code FA 18_Mar17 triggered under the responsibility of the company Becton Dickinson Indústrias Cirúrgicas Ltda. Company will communicate to the customer.