Events

Alerte De Sécurité sur BD Epilor LOR syringe 7 ml with Luer-Lok nozzle, registration no. 10033430533 - Lots - attachment

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..

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
    1299
  • Date
    2013-09-04
  • 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
    If the user does not detect the loss of resistance of the syringe due to the slip with greater resistance that the plunger may present, spinal anesthesia may occur instead of epidural anesthesia. If spinal anesthesia occurs, specific effects with a remote probability of occurrence include headaches and backaches, hypotension, urinary retention, and rare meningitis. Rare effects and unlikely occurrence include severe respiratory depression, hypotension, and decreased heart rate, which requires temporary advanced medical intervention with increased oxygen and administration of medications, or mechanical ventilation until the effects of anesthesia decrease. There are reports of cases in the literature without reports of studies with real incidence, presuming that these types of complications are very rare. In addition, the detection of specific and rarer effects should be part of the routine monitoring of patients receiving anesthesia.////// UPDATE 11/08/2014 - The company finalized the field action. An alert message was sent regarding the use of the product for customers and distributors.
  • Cause
    The bd has so far received 7 world reports indicating that the bd syringe epilor lor 7 ml with luer-lok nozzle may possibly slip with greater strength than usual for a resistance-loss plastic syringe during the ride within the syringe. this occurrence may make it difficult for the user to detect the loss of resistance when entering the epidural space. if this occurs, the user may continue to advance the syringe and needle through the epidural and dural space, and reach the spinal or intrathecal canal, resulting in spinal anesthesia rather than epidural anesthesia. there are no reports of harm to patients.
  • Action
    The company that registers in Brazil, BD, recommends BD Epilor users to: 1. Follow the institution's standard routine procedure to ensure there is no resistance to the syringe before use; 2. If the syringe has this resistance, discard it and continue the procedure with a new syringe; 3. BD Brasil is available to clarify any technical doubts specific to this product and to provide the necessary assistance through the telephone 0800 055 5564 or the email crc@bd.com

Device

BD Epilor LOR syringe 7 ml with Luer-Lok nozzle, registration no. 10033430533 - Lots - attachment

Manufacturer

BECTON DICKINSON INDÚSTRIAS CIRÚRGICAS LTDA.