Adverse events and technical complaints related to central venous catheters marketed in Brazil
Rev. bras. hematol. hemoter
; Rev. bras. hematol. hemoter;35(3): 192-197, jun. 2013. tab, graf
Article
em En
| LILACS
| ID: lil-681966
Biblioteca responsável:
BR408.1
Localização: BR408.1
ABSTRACT
Aim:
The objective of this study was to critically analyze data of the National Notification System for Adverse Events and Technical Complaints (Notivisa) related to central venous catheters, through an evaluation of the description of notifications recorded between 2006 and 2009.Methods:
Notifications were categorized and evaluated to (i) determine the number of adverse events and technical complaints, (ii) verify compliance with the classification criteria defined by the legislation, (iii) reclassify notifications, when necessary, in order for them to fit in with the legal definitions, (iv) verify registered companies in Brazil, (v) quantify the notifications according to the registered company and product lot, and (vi) identify the country of original of the notified product. Microsoft Excel® 2010 was used to categorize and systematize the data.Results:
Some conceptual errors and incomplete records were found. Altogether, 228 notifications of technical complaints and 119 of adverse events were identified. Some notifications on guidewires and broken catheters were reported which led to the necessity of duplicating some medical procedures and to the occurrence of lesions/lacerations of vessels and tissue injury. Forty-seven percent of companies presented at least one notification in Notivisa and in all, 38 product lots had more than one notification.Conclusion:
These data support a necessity for cooperation between all entities of the ...Palavras-chave
Texto completo:
1
Coleções:
01-internacional
Base de dados:
LILACS
Assunto principal:
Vigilância Sanitária
/
Agência Nacional de Vigilância Sanitária
/
Catéteres
/
Cateteres Venosos Centrais
Tipo de estudo:
Prognostic_studies
/
Screening_studies
País/Região como assunto:
America do sul
/
Brasil
Idioma:
En
Revista:
Rev. bras. hematol. hemoter
Assunto da revista:
HEMATOLOGIA
Ano de publicação:
2013
Tipo de documento:
Article
País de afiliação:
Brasil
País de publicação:
Brasil