Events

Alerte Ou Avis De Sécurité sur Unomedical high concentration oxygen masks (specific lots)

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.

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
  • Numéro de l'événement
    MDA/2017/019
  • Date
    2017-07-10
  • Date de publication de l'événement
    2017-07-10
  • 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/unomedical-high-concentration-oxygen-masks-specific-lots-risk-of-hypoxia-as-the-tubing-can-disconnect-from-the-oxygen-mask
  • 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
  • Cause
    Manufactured by convatec – due to a manufacturing fault, the tubing may disconnect from the oxygen mask, prior to use or during use, causing a disruption in the supply of oxygen to patients (mda/2017/019).
  • Action
    Identify and stop using affected devices (see below). Quarantine all affected devices in stock. Contact ConvaTec to acknowledge receipt of the Field Safety Notice (dated 10 May 2017) even if you don’t have affected devices left in stock For any product replacements required, see Field Safety Notice for further details

Device

Unomedical high concentration oxygen masks (specific lots)
  • Modèle / numéro de série
  • Description du dispositif
    The following model (REF number) and LOT numbers are affected:Product Code / REF No. SAP Code Description LOT No’s. NHS Supply Chain Codes (NPC) FDD 104MM 1302097 Rebreathing mask, Reservoir bag, with Tubing 105631   106MM 1702436 Oxygen Mask, Adult High Concentration Non-Rebreather 2.1 m (7’) Oxygen Tubing 100733, 104106, 104798, 100721, 109824 763 108-E 1300168 Non-Rebreather Oxygen Mask, Adult High Concentration with 2.1 m (7’) Oxygen Tubing 102766, 102785, 102726, 102352, 105451, 109186   108MM 1705302 Non-Rebreather Oxygen Mask, Adult High Concentration with 2.1 m (7’) Oxygen Tubing 100281, 100709, 100729, 101923, 103180, 103265, 103691, 103714, 104104, 105987, 110558 2747 3226-E 1308753 Non-Rebreather Oxygen Mask, Pediatric High Concentration with 2.1 m (7’) Oxygen Tubing 102727   3226MM 1307553 Non-Rebreather Oxygen Mask, Pediatric High Concentration with 2.1 m (7’) Oxygen Tubing 100720, 101141   3230MM 1302405 Non-Rebreather Oxygen Mask, Pediatric High Concentration with 2.1 m (7’) Oxygen Tubing 104906, 105181 766 9108MM 1267152 Non-Rebreather Oxygen Mask, Adult High Concentration with 2.1 m (7’) Oxygen Tubing 100232, 100694, 100918, 101639, 101897, 103067, 104846, 104848, 105453
  • Manufacturer
    ConvaTec

Manufacturer

ConvaTec
  • Adresse du fabricant
    Rebecca Evans ConvaTec LimitedTelephone: 01244 284896
  • Société-mère du fabricant (2017)
    Triona Holding Sa
  • Source
    MHRA