Events

Safety Alert for Insyte AutoGuard Intravenous Catheters; In the Catalog. (1) 381412, (2) 381423, (3) 381433, (4) 381434, (5) 381437, (6) 381444, (7) 381447, (8) 381454, (9) (11) 381523, (12) 381533, (13) 381534, (14) 381544;

According to Agência Nacional de Vigilância Sanitária (ANVISA), this safety alert involved a device in Brazil that was produced by BD Infusion Therapy Systems.

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
    179
  • Date
    2000-02-24
  • 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
    BRAZIL-21.12.2001. The company reports that on September 18, 2001, Becton Dickinson & company; through its BD medical systens division, notified the FDA that it had identified through its own controls that batches 106170 and 108010 of the catheter insyte autoguard product, manufactured in its the sandy, utah-usa plant had micro-holes in the primary packaging. In order to prevent potential risks of adverse effects, the company voluntarily decided to collect these lots from the market. He also reports that no notification was sent to foreign governments by Becto Dickison's subsidiary due to the fact that the product was exclusively distributed on the American market.
  • Reason
    Lots nos .: (1) 909170, 910152, 910171, 911151, 911164, 912160; (2) 909166, 909169, 909179, 909172, 909172, 909172, 909181, 910153, 910163, 910163, 910170, 910172, 910175, 910180, 910186, 911187, 911167, 911161, 911163, 911166, 911173, 911177, 912153, 912155, 912158, 912161 , 912165, 912174, 912180, 912183, 001152, 001157, 001163, 001171; (3) 909173, 910151, 910154, 911158, 912151, 912167; (4) 907176, 907177, 908166, 908175, 908176, 909152, 909165, 910157, 910173, 910177, 910182, 911153, 911154, 911169, 911172, 911182, 911185, 912156, 912164, 912166, 912171, 912173, 912176, 912182 , 001151, 001158, 001170; (5) 911176; (6) 909178, 910162, 910164, 910174, 910176, 910179, 911156, 911159, 911165, 911178, 911180, 912152, 912159, 912162, 912169, 912177, 001153, 001159, 001164, 001172; (7) 910169, 912172; (8) 910156; (9) 910167; (10) 910166, 910178, 911168, 911175, 912168; (11) 908177, 910161, 910183, 911179, 912154, 912185, 001162; (12) 910181, 911152, 912157; (13) 908172, 909179, 910165, 911155, 911170, 912179, 001160; (14) 910184, 911171, 912175 the mentioned catheters may cause epithelial irritation at the catheter insertion sites. the manufacturer initiated a mail-order and visit removal, shipped on february 23 and 24, 2000.
  • Action
    Make sure that you have been contacted by BD Infusion Therapy Systems. Identify and isolate any affected product from your inventory. Contact BD Infusion Therapy Systems at the address listed to make arrangements for returning the product and obtaining the replacement product. For more information, contact your local BD representative or Rand Pugmire, recall coordinator, at (801) 565-2550 in the United States.

Device

Insyte AutoGuard Intravenous Catheters; In the Catalog. (1) 381412, (2) 381423, (3) 381433, (4) 3...

Manufacturer

BD Infusion Therapy Systems
  • Source
    ANVSANVISA