Events

Alerte De Sécurité sur 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

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 Becton Dickinson Indústrias Cirúrgicas Ltda.; BECTON DICKINSON AND COMPANY.

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
    2273
  • Date
    2017-04-19
  • 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
    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.
  • Cause
    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