Events

Alerte De Sécurité sur Hypodermic Syringes Plastic BD - See Annex I

Selon Agência Nacional de Vigilância Sanitária (ANVISA), ce/cet/cette alerte de sécurité concerne un dispositif en/au/aux/à Brazil qui a été fabriqué par BECTON DICKINSON INDÚSTRIAS CIRÚRGICAS LTDA.; Becton Dickinson and Company.

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
  • ID de l'événement
    1698
  • Date
    2015-10-09
  • Pays de l'événement
    Brazil
  • Source de l'événement
    ANVISA
  • URL de la source de l'événement
    http://www.anvisa.gov.br/sistec/alerta/consultaralerta.asp
  • Notes / Alertes
    Brazilian data is current through June 2018. All of the data comes from Anvisa, 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 Brazil.
  • Notes supplémentaires dans les données
    The company informs that the health risk related to the storage of drugs in hypodermic syringes (use in disagreement with the purpose of the product) is the decrease in potency and, consequently, the potential need for an additional dosage. Medications identified so far as potentially impacted are used for pain control and / or as a component of a controlled anesthetic procedure. They are always used by healthcare professionals in a monitored environment with immediate reaction capacity for intervention, ranging from additional dosing of medications to life support systems if needed. Also, frequent monitoring and scheduling of medication is within the standard medical practices for these drugs, in which the dosage for each patient is individualized, based on the response of the medication to the medication.
  • Cause
    Recently the bd in the united states has received reports of decreased potency of some drugs when stored in sterile hypodermic syringes of bd plastic. that is, when the syringes are not used right after filling. based on the reports received, it was identified that the cause of the decrease in potency is related to the interaction of some drugs with the cork used in sterile hypodermic syringes of plastic bd when they are stored. this situation encompasses all 1ml, 3ml, 5ml, 10ml, 20ml bd syringes, bd plastipak insulin syringe 1 ml and anesthesia trays where the syringes in question are present. bd ultra-fine syringes for insulin, bd posiflush saline and heparin, pharmaceutical validated syringes for pharmaceutical containers (hypak and sterifill) and 60 ml bd syringes are not impacted. to date, decreased potency of drugs stored in the bd syringes has been reported for: fentanyl, rocuronium, neostigmine, morphine, midazolam, methadone, atropine, hydromorphone, cisatracurium, and remifentanil. the bd confirms the information that sterile hypodermic bd plastic syringes have been developed, manufactured and registered for aspiration and injection soon after filling. such syringes should not be used for drug storage as they are not designed and manufactured for this purpose. we emphasize that to date, no adverse events related to this problem have been reported.
  • Action
    Becton Dickinson Industries Surgical Ltda confirms the information that sterile hypodermic BD plastic syringes have been developed, manufactured and registered for aspiration and injection soon after filling. Such syringes should not be used for the storage of medicines, as they were not designed and manufactured for this purpose. We remind you that if you are using sterile hypodermic BD plastic syringes according to the purpose of use (aspiration followed by injection) and not for storage prior to administration, you can continue to use any of the products. The BD is available to clarify any specific technical doubts and provide the necessary assistance through its telephone 0800 055 5654 or by e-mail

Device

Hypodermic Syringes Plastic BD - See Annex I

Manufacturer

BECTON DICKINSON INDÚSTRIAS CIRÚRGICAS LTDA.; Becton Dickinson and Company