Events

Safety Alert for CONNECTA INFUSAO TAPE. lots: 0901191, 0901192, 1001191, 10011192, 1001193, 1001194, 1101191, 1101192, 120119, 1201192, 0102191, 0102192, 0102193, 0102194, 0102195, 0102196, 0202191, 0202192, 0302191,0302192, 0302193,0302194,0302195, 402191, 0402192 , 0502191, 05021940602191, 0602192, 2179461, 2192871, 2198477, 2212765, 2218342, 2219382, 2221501

According to Agência Nacional de Vigilância Sanitária (ANVISA), this safety alert involved a device in Brazil that was produced by BECTON DICKNSON INDUSTRIA CIRCURGICAS LTDA.

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
    675
  • Date
    2002-09-23
  • 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
    Manufacturing, sale and distribution are voluntarily suspended as a precautionary measure until BD Quality Assurance Engineering completes the investigations into the cause of the occurrences and finds remedial action to eliminate the incompatibility, returning to the product its design characteristics and its normal conditions of use. For more information: Becton Dickinson Technical Support at (11) xx 5185-9855 or Fax (11) xx 5185-9877
  • Reason
    The company has found that when the infusion tap, belonging to the number of batches identified, is installed in intravenous infusion lines to a transfusor, other than from the manufacture of the bd, there may be a crack in the body of the tap, characterizing the connection incompatibility of the components . incompatibility results in dripping of the infusion solution through the body of the tap.
  • Action
    The company understands that the faucet has been developed and manufactured to be compatible as the universal transfusers on the market and no adverse events are expected from these connections. The Company hereby informs that it has initiated voluntary collection of lots 0901191, 0901192, 1001191, 10011192, 1001193, 1001194, 1101191, 1101192, 120119, 1201192, 0102191, 0102192, 0102193, 0102194, 0102195, 0102196, 0202191, 0202192 , 0302191,0302192, 0302193,0302194,0302195, 402191, 0402192, 0502191, 05021940602191, 0602192, 2179461, 2192871, 2198477, 2212765, 2218342, 2219382, 2221501

Device

CONNECTA INFUSAO TAPE. lots: 0901191, 0901192, 1001191, 10011192, 1001193, 1001194, 1101191, 1101...

Manufacturer

BECTON DICKNSON INDUSTRIA CIRCURGICAS LTDA
  • Source
    ANVSANVISA