Events

Alerte De Sécurité sur BD PrecisionGlide Hypodermic Needle, registration no. 10033430019 - lot 9149041

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..

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
    1619
  • Date
    2015-07-03
  • 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 PrecisionGlide needle is made from stainless steel, plastic resins, glue and silicone. Essentially, each of these materials is stable and must provide mechanical stability to the product even after the expiration date. The risk with the product is related to the barrier of the sterile packaging. If the package degrades after the expiration date, this may result in a breach of the sterile barrier. No reports of adverse events related to the use of this product have yet been received after expiration.
  • Cause
    In june 2015, the bd company was notified that, as a result of a mixture of lots at the warehouse of sanofi-aventis farmacêutica ltda., 5,016 units of precisionglide needle 0.60 x 25mm lot 9149041 were dispatched and delivered together with lot 3056430 . the expedition took place in june / 2015. from that same lot (lot 9149041) 3,057 needles were dispatched and delivered together with the lot. in this case the shipment occurred between january / 2013 and july / 2014. the investigation carried out by bd brasil and sanofi showed that the mixture occurred in the logistic operator of the warehouse of the company sanofi, where the lots were stored in the same pallet position and later delivered in bonus to the customers who purchased the adacel vaccine. therefore, this notice only affects healthcare institutions that eventually physically received lot 9149041 as part of the bonus linked to the acquisition of adacel (single-dose vial vaccine). lot 9149041 has expired expiration date.
  • Action
    Some users of the Adacel Vaccine received mixed batches. So this alert and your actions are focused on this audience. Sanofi advised customers that they received the batches of PrecisionGlide Needle affected by this mix by sending a letter, directing them to take the following actions: 1. Immediately conduct the inventory survey to identify and segregate lot 9149041; 2. Do not use any unit of lot 9149041; 3. Contact Sanofi Pasteur through Telesales 0800 11 90 20 or by e-mail televendas.brasil@sanofipasteur.com

Device

BD PrecisionGlide Hypodermic Needle, registration no. 10033430019 - lot 9149041

Manufacturer

BECTON DICKINSON INDÚSTRIAS CIRÚRGICAS LTDA.