Events

Safety Alert for BD 60 mL syringe, Registration 10033430626 - Lot: 4232677

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
    1681
  • Date
    2015-08-28
  • 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 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.
  • Reason
    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