Events

Safety Alert Or Field Safety Notices for Unomedical high concentration oxygen masks (specific lots)

According to Medicines and Healthcare products Regulatory Agency, this safety alert or field safety notices involved a device in United Kingdom that was produced by ConvaTec.

What is this?

Field safety notices are communications sent out by medical device manufacturers or their representatives in relation to actions that they may be taking in relation to their product that is on the market. These are mainly for health workers, but also for users. They can include recalls and alerts.

Learn more about the data here
  • Type of Event
    Safety alert / Field Safety Notice
  • Event Number
    MDA/2017/019
  • Date
    2017-07-10
  • Event Date Posted
    2017-07-10
  • Event Country
    United Kingdom
  • Event Source
    MHRA
  • Event Source URL
    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 / Alerts
    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.
  • Extra notes in the data
  • Reason
    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)
  • Model / Serial
  • Product Description
    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
  • Manufacturer Address
    Rebecca Evans ConvaTec LimitedTelephone: 01244 284896
  • Manufacturer Parent Company (2017)
    Triona Holding Sa
  • Source
    MHRA