Events

Alerte De Sécurité sur BD Plastipak Hypodermic Syringe without Needle 20mL registration no. 10033430030 - Lots - 4161132 and 4227147 - Client List - Attachment 1

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
    1613
  • Date
    2015-06-19
  • 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
    According to the risk assessment performed by the BD Medical Department, the health risk was classified as limited severity and unlikely occurrence, resulting in a low health risk index (green zone). This classification of severity and occurrence indicates that this defect is unlikely to trigger the need for medical or surgical intervention in order to prevent permanent impairment of a function or structure of the organism. The medical evaluation concluded that the partially opened sealing defect in the 20 mL syringe has the potential of being noticed by the health care professional before use and the syringe being discarded. If open sealing is not noticed and the syringe is used to prepare medication, it is unlikely that any microorganism has migrated to the fluid path. In addition, considering that a sterile needle must be attached to the syringe for aspiration procedures of blood or body fluids there is no health risk in these procedures when performed with this product.
  • Cause
    Bd received a customer complaint stating that some units of lot 4161132 had the packaging open. samples were sent to the manufacturer for evaluation, which confirmed that the packages were partially opened in the sealing area. an investigation was initiated and identified that the batch was produced with the forming temperature outside the one specified in the validation, which may lead to the occurrence of the partially open sealing defect. this defect impacts the integrity of the package and can potentially affect the sterility of the product. during the verification of the comprehensiveness of the situation, it was identified that lot 4227147 was also manufactured at a temperature outside the specified range. although the bd received no complaints and had not found any open sealed unit for lot 4227147 during the investigation, it was still decided to start the recall procedure for the two batches. the company informs that to date, no adverse events related to this product have been registered.
  • Action
    BD has communicated the clients affected by this field action by sending a letter, which directs them to take the following actions: 1. Immediately survey their inventory to identify the catalog and batches affected, segregating all units. 2. Block all available units in your stock and immediately discontinue use of the product; 3. Complete the fields of the form attached to the letter, sending it to regulatorio@bd.com or fax (011) 5185-9937, regardless of whether or not you still own the units affected by this action. For more information, see Annex II - Customer Notice.

Device

BD Plastipak Hypodermic Syringe without Needle 20mL registration no. 10033430030 - Lots - 4161132...

Manufacturer

BECTON DICKINSON INDÚSTRIAS CIRÚRGICAS LTDA.