Events

translation missing: en.activerecord.attributes.event.titles.recall_field_safety_notice

According to Saudi Food & Drug Authority, this translation missing: en.activerecord.attributes.event.types.recall_field_safety_notice involved a device in Saudi Arabia that was produced by Codman & Shurtleff Inc.

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
    Recall / Field Safety Notice
  • Event ID
    mdprc 179 08 13 000
  • Event Initiated Date
    2013-08-28
  • Event Country
    Saudi Arabia
  • Event Source
    SFDA
  • Event Source URL
    https://ncmdr.sfda.gov.sa/Secure/CA/CaViewRecall.aspx?caid=5&rid=4282
  • Notes / Alerts
    Saudi data is current through January 2019. All of the data comes from the Saudi Food & Drug Authority, 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 Saudi Arabia.
  • Extra notes in the data
    Report Source: NCAR
    SFDA urges all hospitals that have devices subjected to recall, to contact the company.
  • Reason
    An on-going investigation into complaints for increased drug flow rates exceeding programmed flow rates revealed the possibility that air introduced into the pump reservoir during filling/re-filling can result in air bubble expansion which can cause increased expulsion of drug into the patient when the valve opens.

Device

Infusion pump , MedStream Programmable Infusion System
  • Model / Serial
    91-4200 MedStream Programmable Pump; 20mL 91-4201 MedStream Programmable Pump; 40mL 91-4289 MedStream Refill Kit 91-4290 MedStream Refill Kit; 6 pack
  • Product Classification
    General Hospital and Personal Use Devices
  • Product Description
    MedStream Programmable Infusion System
  • Manufacturer
    Codman & Shurtleff Inc

Manufacturer

Codman & Shurtleff Inc
  • Manufacturer Parent Company (2017)
    Johnson & Johnson
  • Manufacturers representative
    FAROUK, MAAMOUN TAMER & COMPANY , Riyadh , (011) 4142200
  • Source
    SFDA