Events

Alerte Ou Avis De Sécurité sur Potentially breached sterile packaging of

Selon Medicines and Healthcare products Regulatory Agency, ce/cet/cette alerte ou avis de sécurité concerne un dispositif en/au/aux/à United Kingdom qui a été fabriqué par ConvaTec Limited.

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
    Safety alert / Field Safety Notice
  • Date
    2019-02-28
  • Date de publication de l'événement
    2019-02-28
  • Pays de l'événement
    United Kingdom
  • Source de l'événement
    MHRA
  • URL de la source de l'événement
    https://www.gov.uk//drug-device-alerts/potentially-breached-sterile-packaging-of-rectal-tubes-unoversal-drainage-systems-simpavac-sterile-suction-connecting-tubes-sterile-connecting-pieces-suction-handles-sets-filterflow-deltaflo-oxygen-catheters-sterile-nasal-oxygen-c
  • Notes / Alertes
    Data from the United Kingdom is current through April 2019. All of the data comes from the Medicines and Healthcare products Regulatory Agency, 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 recall data from the U.S. and the United Kingdom.
  • Notes supplémentaires dans les données
    Manufactured by ConvaTec Limited - use of affected devices may increase risk of patients acquiring infections – extension to MDA/2018/034 as additional devices are affected
  • Cause
    Manufactured by convatec limited - use of affected devices may increase risk of patients acquiring infections – extension to mda/2018/034 as additional devices are affected.
  • Action
    Identify if you have any affected devices - check the manufacturer's Field Safety Notice (FSN) dated 04 Jan 2019 for a list of affected product codes and lots. Stop using and quarantine affected devices as instructed in the manufacturer's FSN. Complete the 'Recall Response Form for END USERS' in the FSN, even if you don't have affected devices left in stock, and return it to convatecproductrecall@stericycle.com to arrange return of affected devices. Report any incidents or complaints involving this product to unomedical-uk.customerservice@convatec.com and through your local incident reporting system and/or your national incident reporting authority as appropriate: England, Scotland, Northern Ireland, Wales. Note that this is an extension to MDA/2018/034 as more affected products have been identified. None of the products listed in the latest FSN were listed in the previous version of the FSN.Action byAll healthcare professionals who are responsible for or who use these devicesDeadlines for actionsActions underway:21 March 2019Actions complete:29 April 2019Medical Device Safety Officers (in England): ask the manufacturer to add you to their distribution list for field safety notices (FSNs). This is to help with reconciliation.Remember : if your organisation receives an FSN from a manufacturer, always act on it. Do not wait for a communication from MHRA.

Device

Potentially breached sterile packaging of
  • Modèle / numéro de série
  • Description du dispositif
    The breach in the packaging is not visible so affected devices can only be identified by comparing product code/REF and LOT/Batch Number stated on the packaging to the product list in attachment 1 of the manufacturer's FSN.
  • Manufacturer
    ConvaTec Limited

Manufacturer

ConvaTec Limited
  • Adresse du fabricant
    ConvaTec LimitedTel: 01244 832206Email: convatecproductrecall@stericycle.comunomedical-uk.customerservice@convatec.com
  • Société-mère du fabricant (2017)
    Triona Holding Sa
  • Source
    MHRA