Events

Alerte De Sécurité sur CATETER BD HYDROCATH

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 DICKISON.

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
    90
  • Date
    2001-10-11
  • 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
    BRAZIL - 11/10/2001 - INFORMS THAT PROTOCOLED TO ANVISA-NATIONAL AGENCY OF SANITARY SURVEILLANCE - BRAZIL, (PROTOCOL No. 123660/11) REQUEST FOR AMENDMENT OF PRODUCT NAME FOR BD CATHETER INTRAVENOUS CENTRAL HYDROCATH AND ACCESSORIES. ALTERATION OF LABELING: "AGAINST INDICATION - DO NOT USE IN DIFFERENT PEDIATRICS SUSPECTING IMMEDIATE REACTIONS OF TYPE HYPENSENSILITY, THE INTRAVENOUS CATHETER BD HYDROCATH SHOULD NOT BE USED IN PATIENTS WITH A WEIGHT BELOW 20 KG WARNING - HAS BEEN SUSPECTED OF CASES ISOLATED OF TYPICAL REACTIONS HYPERSENSITIVITY IN PATIENTS TREATED WITH BD HYDROCATH INTRAVENOUS CATHETER: AS A PRECAUTIONARY MEASURE, THE POSSIBILITY OF THE OCCURRENCE OF SUCH REACTIONS SHOULD BE CONSIDERED WHEN USING THIS CATHETER "
  • Cause
    Occurrence of rare cases of immediate types of hypersensitivity reactions during the use of bd hydrocath central and arterial cathederes - 1 reaction / 60,000 catheters, 80% of which is verified in pediatric cases.
  • Action
    CONSIDERING THE SUSPECTED INCIDENT, THE COMPANY HAS DECIDED TEMPORARILY TO SUSPEND THE MARKETING OF CATHETER HYDROCATH IN ALL COUNTRIES WHERE IT DID BUSINESS WHERE THAT ANALYTICAL TESTS AND RISK ASSESSMENT LEADED BY EXPERTS FROM THE HEALTH AREA OF GERMANY AND ENGLAND SEARCH THE EXISTENCE OF A RELATIONSHIP OF CASUALITY BETWEEN THE INCIDENT AND THE DEVICE. IT ALSO REPORTS, THAT BY PRECAUTION, ALERTED THE MEDICAL COMMUNITY, THROUGH * NOTICE INSERTED IN THE PACKAGE AND PROTOCOL TO ANVISA-NATIONAL AGENCY OF SANITARY SURVEILLANCE- BRAZIL, REQUEST OF ALTERATION OF LABELING. WITH THE FOLLOWING INFORMATION: * "AGAINST INDICATION - DO NOT USE IN DIFFERENT PEDIATRICS SUSPECTED OF IMMEDIATE REACTIONS OF THE TYPE HYPENSENSILITY, THE INTRAVENOUS CATHETER BD HYDROCATH SHOULD NOT BE USED IN PATIENTS WITH A WEIGHT BELOW 20 KILOS WARNING - HAS BEEN SUSPECTED OF CASES ISOLATED OF REACTIONS OF THE TYPE HYPERSENSITIVITY IN PATIENTS TREATED WITH INTRAVENOUS CATHETER BD HYDROCATH. AS A PRECAUTIONARY MEASURE, THE POSSIBILITY OF THE OCCURRENCE OF SUCH REACTIONS SHOULD BE CONSIDERED WHEN USING THIS CATHETER "

Device

CATETER BD HYDROCATH

Manufacturer

BECTON DICKISON
  • Source
    ANVSANVISA