Events

Safety Alert Or Field Safety Notices for BD Plastipak 100ml catheter tip syringe with Luer slip adaptor, 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 Becton Dickinson.

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
  • Date
    2017-04-24
  • Event Date Posted
    2017-04-24
  • Event Country
    United Kingdom
  • Event Source
    MHRA
  • Event Source URL
    https://www.gov.uk//drug-device-alerts/bd-plastipak-100ml-catheter-tip-syringe-with-luer-slip-adaptor-specific-lots-risk-of-leakage-and-delayed-therapy
  • 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 becton dickinson (bd) – product recall due to leak around the stopper which can result in under-dose or exposure of clinicians or patients to cytotoxic drugs.
  • Action
    Identify all lots of syringes that have an expiry date up to and including April 2021. Ensure all users are aware of the manufacturer’s Field Safety Notice published in February 2017. Contact the manufacturer to acknowledge the FSN and arrange to return affected syringes for replacement.

Device

BD Plastipak 100ml catheter tip syringe with Luer slip adaptor, specific lots
  • Model / Serial
  • Product Description
    BD catalogue number 300605.Note: These syringes may be included in clinical/surgery packs supplied by other companies so this catalogue number might not appear or be obvious.
  • Manufacturer
    Becton Dickinson

Manufacturer

Becton Dickinson
  • Manufacturer Address
    BD Medical Tel: 01865 781 534Email andrew.milton@bd.com
  • Manufacturer Parent Company (2017)
    Becton, Dickinson and Company
  • Source
    MHRA