Events

Alerte De Sécurité sur Becton-Dickinson (BD) 3 millilitre (ml) and 5 ml syringes

Selon Department of Health, ce/cet/cette alerte de sécurité concerne un dispositif en/au/aux/à Hong Kong qui a été fabriqué par BD.

Qu'est-ce que c'est?

Les alertes fournissent des informations importantes et des recommandations concernant les dispositifs médicaux. Le fait qu'une alerte soit émise ne signifie pas nécessairement qu'un dispositif soit dangereux. Les alertes de sécurité, qui sont envoyées tant aux travailleurs du secteur médical qu'aux utilisateurs de ces dispositifs, peuvent inclure des rappels. Elles peuvent être rédigées par des fabricants mais aussi par des autorités en charge de la santé.

En savoir plus sur les données ici
  • Type d'événement
    Safety alert
  • Date
    2015-08-21
  • Date de publication de l'événement
    2015-08-19
  • Pays de l'événement
    Hong Kong
  • Source de l'événement
    DH
  • URL de la source de l'événement
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20150821.html
  • Notes / Alertes
    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.
  • Notes supplémentaires dans les données
    Medical Device Safety Alert
  • Cause
    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
  • Modèle / numéro de série
  • Description du dispositif
    Medical Device Safety Alert: Becton-Dickinson (BD) 3 millilitre (ml) and 5 ml syringes
  • Manufacturer
    BD

Manufacturer

BD