Events

Alerta De Seguridad para BD MAX Vaginal Panel and BD MAX UVE Specimen Collection Kit

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

¿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
    2017-07-31
  • Fecha de publicación del evento
    2017-07-31
  • País del evento
    Hong Kong
  • Fuente del evento
    DH
  • URL de la fuente del evento
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20170731.html
  • 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.
  • Notas adicionales en la data
    Medical Device Safety Alert
  • Causa
    Medical device safety alert: bd max vaginal panel and bd max uve specimen collection kit medical device manufacturer, bd, has issued a medical device safety alert concerning its bd max vaginal panel [catalogue number: 443712, 443710] and bd max uve specimen collection kit [catalogue number: 443376]. the manufacturer is currently conducting an investigation into customer complaints regarding an increased rate of unresolved (unr) and indeterminate (ind) results for the bd maxtm vaginal panel. a non-reportable result may lead to repeat of the test and/or re-collection of a specimen. data from the investigation suggest that this issue is related to certain specimen collection practices, including the use of lubricants. information is intended to provide clinicians and patients with precautions in relation to current package insert instructions included with bd max uve specimen collection kits. product returns or discards are not required. clinicians and patients are advised to follow the precautions provided by the manufacturer. according to the local supplier, the affected products are distributed in hong kong if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 31 july 2017.

Device

BD MAX Vaginal Panel and BD MAX UVE Specimen Collection Kit
  • Modelo / Serial
  • Descripción del producto
    Medical Device Safety Alert: BD MAX Vaginal Panel and BD MAX UVE Specimen Collection Kit
  • Manufacturer
    BD

Manufacturer

BD