Alerta De Seguridad para Nonvented Y-Set

Según Department of Health, este evento ( alerta de seguridad ) involucró a un dispositivo médico en Hong Kong que fue producido por Hospira.

¿Qué es esto?

Las alertas proporcionan información importante y recomendaciones sobre los productos. Aunque se haya emitido una alerta, esto no significa necesariamente que el producto se considera peligroso. Las alertas de seguridad, dirigidas a trabajadores de la salud y a usuarios, pueden incluir retiro de equipos. Pueden ser escritas por los fabricantes, pero también por funcionarios del área de salud.

Más información acerca de la data acá
  • Tipo de evento
    Safety alert
  • Fecha
    2014-04-17
  • Fecha de publicación del evento
    2014-04-17
  • País del evento
  • Fuente del evento
    DH
  • URL de la fuente del evento
  • Notas / Alertas
    Hong Kong data is current through September 2018. All of the data comes from the Department of Health (Hong Kong), 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 Hong Kong.
    ICU Medical, Inc. acquired from Pfizer in early 2017, Hospira Infusion Systems, the portion of Hospira dedicated to develop infusion pumps.
  • Notas adicionales en la data
    Medical Device Safety Alert
  • Causa
    Medical device safety alert: hospira nonvented y-set medical device manufacturer, hospira, has issued a medical device safety alert concerning its nonvented y-set for transurethral resection (list number: 06543-01). the impacted batches are 13106ns, 13170ns, 13251ns, 14261ns, 14262ns, 15139ns, 16117ns, 17131ns, 17132ns, 17184ns, 18110ns, 18111ns, 18182ns, 19133ns, 20122ns, 20123ns, 20124ns, 20205ns, 22146ns, 22147ns, 22148ns, 22149ns, 23103ns, 23104ns, 23105ns, 23106ns, 24156ns, 25130ns, 25131ns, 27109ns, 27253ns, 27286ns, 28136ns, 28137ns, 29094ns, 29095ns, 29096ns, 30194ns, 30195ns, 30196ns, 31042ns, 31043ns, 32229ns, 32230ns, 33138ns, 33139ns, 33140ns, 34286ns and 35117ns. in the complaint review, the manufacturer has discovered the issue of incomplete sealing in the secondary package of the affected batches of devices. the issue occurred either because the sterile pack was not sealed properly or the tyvek cover sheet was not centered on the bottom tray of the pack, allowing openings at the edge of the sterile package. the open packaging of the affected product may lead to loss of product sterility, delay in initiating therapy, introduction of infectious agent and particulate onto the surface of the irrigation set. up to date, the manufacturer did not receive any complaint or adverse reporting associated with the incomplete sealing of the package. the manufacturer advises affected users not to use the package if it is not intact. according to the manufacturer, the affected products were distributed in hong kong. if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 17 april 2014.

Device

  • Modelo / Serial
  • Descripción del producto
    Medical Device Safety Alert: Hospira Nonvented Y-Set
  • Manufacturer

Manufacturer

  • Empresa matriz del fabricante (2017)
  • Source
    DH