Events

Safety Alert for 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

According to Agência Nacional de Vigilância Sanitária (ANVISA), this safety alert involved a device in Brazil that was produced by Becton Dickinson Indústrias Cirúrgicas Ltda.; BECTON DICKINSON AND COMPANY.

What is this?

Alerts provide important information and recommendations about products. Even though an alert has been issued, it does not necessarily mean a product is considered to be unsafe. Safety Alerts, addressed to health workers and users, may include recalls. They can be written by manufacturers, but also by health officials.

Learn more about the data here
  • Type of Event
    Safety alert
  • Event ID
    2273
  • Date
    2017-04-19
  • Event Country
    Brazil
  • Event Source
    ANVISA
  • Event Source URL
    http://www.anvisa.gov.br/sistec/alerta/consultaralerta.asp
  • Notes / Alerts
    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.
  • Extra notes in the 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 consultor_vacutainer@bd.com in order to clarify any possible doubts to its customers.
  • Reason
    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.
  • Action
    Field Action Code FA 18_Mar17 triggered under the responsibility of the company Becton Dickinson Indústrias Cirúrgicas Ltda. Company will communicate to the customer.

Device

BD Vacutainer Glass Tubes with Vacuum Blood Collection Reagents Technical Name: BOTTLE OR MATERIA...

Manufacturer

Becton Dickinson Indústrias Cirúrgicas Ltda.; BECTON DICKINSON AND COMPANY