Events

Alerta De Seguridad para Becton-Dickinson (BD) 3 millilitre (ml) and 5 ml syringes

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
    2015-08-21
  • Fecha de publicación del evento
    2015-08-19
  • País del evento
    Hong Kong
  • Fuente del evento
    DH
  • URL de la fuente del evento
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20150821.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: becton-dickinson (bd) 3 millilitre (ml) and 5 ml syringes the united states food and drug administration (fda) has issued a safety alert concerning compounded drugs stored in becton-dickinson (bd) 3 millilitre (3ml) and 5ml syringes. fda is alerting health care professionals not to administer to patients compounded or repackaged drugs that have been stored in 3 ml and 5ml syringes manufactured by bd unless there is no suitable alternative available. preliminary information indicates that drugs stored in these syringes may lose potency over a period of time due to a possible interaction with the rubber stopper in the syringe. fda gives the following recommendations:  hospital and pharmacy staff should check supply stocks and remove drug products that were filled by pharmacies or outsourcing facilities and stored in general purpose bd 3ml and 5ml syringes. these syringes are marked with the bd logo at the base of the syringe. at this time, fda does not have information on how long drugs can be stored in these syringes before degrading. there is no information to suggest that there is a problem with potency or drug degradation when medication is administered promptly after the syringes are filled.  this warning does not extend to products approved by fda for marketing as pre-filled syringes, because as part of the approval process, fda has determined that these products have been shown to maintain stability in the syringe container through the expiration date on the product. the fda is continuing to investigate this issue and will provide more information when it is available. for details, please refer to the fda websites: http://www.Fda.Gov/safety/medwatch/safetyinformation/safetyalertsforhumanmedicalproducts/ucm458955.Htm http://www.Fda.Gov/drugs/drugsafety/ucm458952.Htm posted on 19 august 2015.

Device

Becton-Dickinson (BD) 3 millilitre (ml) and 5 ml syringes
  • Modelo / Serial
  • Descripción del producto
    Medical Device Safety Alert: Becton-Dickinson (BD) 3 millilitre (ml) and 5 ml syringes
  • Manufacturer
    BD

Manufacturer

BD