Events

Safety Alert Or Field Safety Notices for PlastipakTM 50ml Luer Lok syringe – sterile

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 BD Medical.

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 ID
    MDA/2013/068
  • Event Number
    CON307409
  • Date
    2013-08-21
  • Event Date Posted
    2013-08-21
  • Event Country
    United Kingdom
  • Event Source
    MHRA
  • Event Source URL
    https://webarchive.nationalarchives.gov.uk/20150113054913/http://www.mhra.gov.uk/PrintPreview/MedicalDeviceAlertSP/CON307409?tabName=allTabs
  • 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
    Risk of under-delivery of medication to patient. syringes from the affected batches may have a dent/indentation on the syringe barrel which may cause leakage inside the syringe, between the plunger and the barrel. bd issued a field safety notice (fsn) on 24 june 2013 recalling the batches affected by this manufacturing problem. note: this notification is different from the earlier recall of plastipaktm 50ml luer lok syringes initiated by bd in april 2013 (mda/2013/024).
  • Action
    Identify, quarantine and do not use syringes from the affected batches.  Return affected syringes, with the customer response card, to the manufacturer.

Device

PlastipakTM 50ml Luer Lok syringe – sterile
  • Model / Serial
  • Product Description
    Single use syringes: PlastipakTM 50ml Luer Lok syringe – sterile. Product code 300865 (England only - NHS Supply Chain code FWC034). Specific lot numbers are affected. Affected lot numbers:
  • Manufacturer
    BD Medical

Manufacturer

BD Medical