Events

Recall of Spinocath G22 / G27 (Spinal anaesthesia kit)

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by B Braun Australia Pty Ltd.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    RC-2016-RN-01228-1
  • Event Risk Class
    Class I
  • Event Initiated Date
    2016-09-21
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2016-RN-01228-1
  • Notes / Alerts
    Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, 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 Australia.
  • Extra notes in the data
  • Reason
    During internal quality checks b. braun discovered that the certain spinocath articles may have holes in the pvc film of the sterile barrier system. there is a risk that microorganisms may penetrate the sterile barrier through the holes in the pvc barrier. thus, contamination is possible and may pose a risk to the patient. the risk of a clinically significant infection has been assessed as low but cannot be excluded. to date no harm or any other adverse patient outcome associated with this issue has been reported.
  • Action
    B. Braun is advising users to inspect stocks and destroy all units from the affected article code. Credit will be provided for all unused/destroyed stock. Records of previous patients should be reviewed and any potentially related infections reported to B. Braun.

Device

Spinocath G22 / G27 (Spinal anaesthesia kit)
  • Model / Serial
    Spinocath G22 / G27 (Spinal anaesthesia kit)Article Number: 4517725All batches affectedARTG Number: 148912
  • Manufacturer
    B Braun Australia Pty Ltd

Manufacturer

B Braun Australia Pty Ltd