title: Adverse events and technical complaints related to central venous catheters marketed in Brazil.
abstract: OBJECTIVE
  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((r)) 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.
  
  
  CONCLUSIONS
  These data support a necessity for cooperation between all entities of the National Health Surveillance System to check compliance of this type of product and to properly report adverse events and technical complaints. It is also important to incorporate minimum standards for the management of technologies in health services, including in the acquisition of products and training of staff.
authors.affiliation: Fundação Oswaldo Cruz, FIOCRUZ, Rio de Janeiro, RJ, Brazil.
authors.forename: Luciene de Oliveira
authors.initials: Lde O
authors.lastname: Morais
authors.forename: Karen
authors.initials: K
authors.lastname: Friedrich
authors.forename: Stela Candioto
authors.initials: SC
authors.lastname: Melchior
authors.forename: Michele Feitoza
authors.initials: MF
authors.lastname: Silva
authors.forename: Andre Luis
authors.initials: AL
authors.lastname: Gemal
authors.forename: Isabella Fernandes
authors.initials: IF
authors.lastname: Delgado
keywords: Brazil; Catheter; Central venous catheter; Health Surveillance; National Health Surveillance Agency
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