Events

Alerte De Sécurité sur BD PrepMate™ Syringing Pipette

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 Diagnostics.

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
    2012-04-27
  • 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_20120427.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
    Field safety notice: bd prepmate™ syringing pipette medical device manufacturer, bd diagnostics, has issued a field safety notice concerning bd prepmate™ syringing pipette shipped between 31 august 2010 and march 2012. the affected devices can be found in the following products: product name catalog no. bd prepstain™ gyn 480 disposable kit 490542 bd prepstain™ suringing pipettes 240 490517 bd prepstain™ gyn 480 disposable test kit with precoat slides 490523 bd prepstain™ installation kit (precoat) 490528 manual method 1:480 test kit (precoat) 490529 according to bd, the affected devices may leak and decrease the dispensing volume of the sample. the root cause is determined to be a dimensional issue with the barrel of the syringe. age of the device may also be a factor in relation to the leaking. bd observed that a leaking pipette is usually at least 6 months old, while some can be as early as 4 months old. bd recommends the affected users to refer to the operator’s manual and inspect the centrifuge tubes so as to make sure correct amount of sample has been transferred. if a pipette is found to be defective, users are suggested to discard the pipette and contact bd for replacement. according to the local supplier, the affected devices have been distributed in hong kong. if you are in possession of the affected product, please contact your supplier for necessary actions.

Device

BD PrepMate™ Syringing Pipette
  • Modèle / numéro de série
  • Description du dispositif
    Medical Device Safety Alert: BD PrepMate™ Syringing Pipette
  • Manufacturer
    BD Diagnostics

Manufacturer

BD Diagnostics