Events

Alerte De Sécurité sur BD 60 mL syringe, Registration 10033430626 - Lot: 4232677

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
    1681
  • Date
    2015-08-28
  • 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 BD informs that considering the high potential of the particles to be noticed by the health professional before the use and the improbability of being expelled, the medical evaluation concluded that the presence of particles in the BD Syringe of 60 mL LL presents a degree of risk to the patient very low. Additionally, the occurrence of an adverse event related to the 60 mL LL Syringe BD product is unlikely given the biocompatibility, very low toxicity of the product and the isolated nature of the particles.
  • Cause
    Bd received 6 customer complaints stating that white particles were present inside some 60 ml ll binding units, lot 4232677. samples were sent to the factory, which confirmed, through visual analysis, the presence of the particles in the sample. identified as being of polypropylene (the raw material constituting the syringe body). according to the investigation, the incident was caused by misalignment of the air injection sensors inside the syringe as a result of jamming in the assembly machine. the sensor misaligned as it entered the syringe body scraped the inner wall of the syringe, resulting in the presence of the particles. an additional test performed on samples from the claimed batch verified that no particles previously identified inside the syringe were expelled. we emphasize that to date, no adverse events related to this problem have been reported.
  • Action
    The BD advises clients to take the following actions: 1. Immediately collect their inventory to identify the affected catalog and batch, segregating all units; 2. Block all available units in your stock and immediately discontinue use of the product; 3. Complete the fields of the form attached to the letter, sending the same to the email regulatory@bd.com or fax (011) 5185-9937, regardless of whether or not you still own the units affected by this action; 4. Upon confirmation of receipt of the form, the BD will contact to align the collection of the affected units and the replacement of the same. The BD is available to clarify any specific technical doubts and provide the necessary assistance through its telephone 0800 055 5654 or through the email crc@bd.com.br.

Device

BD 60 mL syringe, Registration 10033430626 - Lot: 4232677

Manufacturer

BECTON DICKINSON INDÚSTRIAS CIRÚRGICAS LTDA.; Becton Dickinson and Company