Events

Recall of Premicath Neonatal PICC with Stylet Premicath with Stylet

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by Device Technologies 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-2018-RN-00478-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2018-07-05
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2018-RN-00478-1
  • 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
    Device technologies australia (dta) has been made aware by the manufacturer, vygon gmbh & co kg, of reported incidents where the stylet snapped upon removal when the user made a second attempt to remove the stylet from the catheter.
  • Action
    DTA is advising that the Instructions for Use (IFU) has been revised to provide further instructions concerning the removal of the Stylet. The relevant segment is as follows: "In order to remove the stylet, disconnect between the T-Piece and catheter hub. If difficulty is experienced stop, let vein rest for a minute and try removal again very slowly. Gentle flushing of the catheter with diluted lipid solution (preferred) or saline assists in stylet removal. If resistance still remains, withdraw catheter and stylet simultaneously."

Device

Premicath Neonatal PICC with Stylet Premicath with Stylet
  • Model / Serial
    Premicath Neonatal PICC with Stylet Premicath with Stylet Product Code: VY-1261.153 Premicath 1FR 20cm Split NeedleProduct Code: Vy-1261.203 Premicath with Stylette Product Code: VY-1261.205 Premicath W Pink Hub Secure Device Product Code: VY-1261.207 Premicath 1FR 28g 30cm w/stylet Product Code: VY-1261.306 ARTG Number: 141227(Device Technologies Australia Pty Ltd - Catheter, intravascular, general-purpose)
  • Manufacturer
    Device Technologies Australia Pty Ltd

Manufacturer

Device Technologies Australia Pty Ltd