Events

Avis De Sécurité sur BD Vacutainer Multiple Sample Luer Adaptor. Catalogue number: 367300

Selon Health Products Regulatory Authority, ce/cet/cette avis de sécurité concerne un dispositif en/au/aux/à Ireland qui a été fabriqué par BD Diagnostics Preanalytical Systems.

Qu'est-ce que c'est?

Les avis de sécurité sont des communications que les fabricants de dispositifs médicaux ou leurs représentants font parvenir en particulier aux travailleurs du secteur médical, mais aussi aux utilisateurs de ces dispositifs. Les avis de sécurité concernent les actions entreprises quant aux dispositifs présents sur le marché et peuvent inclure des rappels et des alertes.

En savoir plus sur les données ici
  • Type d'événement
    Field Safety Notice
  • Numéro de l'événement
    SN2014(09)
  • Date
    2014-02-28
  • Pays de l'événement
    Ireland
  • Source de l'événement
    HPRA
  • URL de la source de l'événement
    http://www.hpra.ie/homepage/medical-devices/safety-information/safety-notices/item?t=/bd-vacutainer-multiple-sample-luer-adaptor.-catalogue-number-367300&id=bc77f825-9782-6eee-9b55-ff00008c97d0
  • Notes / Alertes
    "Irish data is current through April 2019. All of the data comes from the Health Products Regulatory Authority (Ireland), 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 Ireland."
  • Notes supplémentaires dans les données
  • Cause
    Bd diagnostics preanalytical systems have received an increase in reports of blood leakage when using the bd vacutainer® multiple sample luer adaptor. the blood leakage is attributed to the retractable non-patient cannula (grey) showing non sleeve-recovery, sleeve leakage or sleeve fall-off. bd has also received reports detailing blood leakage at the luer tip connection end, which has the potential to lead to evacuated blood collection tubes not being filled completely.  these issues can lead to an increased risk to users of exposure to blood and a risk of under-filling of blood collection tubes which could lead to unexpected results in some laboratory tests. no adverse incidents of accidental blood exposure or under-filling of the tubes involving the bd vacutainer® multiple sample luer adaptor have been reported to the imb.
  • Action
    he IMB advises that users:  (1) Identify affected lots and ensure that all relevant staff are aware of the recommended actions in the manufacturer’s FSN.  (2) Distribute this notice to healthcare professionals in your organisation who may use the BD Vacutainer® Multiple Sample Luer Adaptor (Product Ref: 367300) and maintain awareness of this safety notice for an appropriate time period.  (3) Complete and return the FSN acknowledgement to BD to indicate receipt and transmission of this FSN in your organisation.  (4) If you have distributed the devices to other healthcare professionals or organisations, forward this notice to those healthcare professionals and organisations.  (5) BD will replace products from affected lot numbers on request. Contact BD for replacement product, if required.

Device

BD Vacutainer Multiple Sample Luer Adaptor. Catalogue number: 367300

Manufacturer

BD Diagnostics Preanalytical Systems