Events

Safety Alert for AMED Mucus Trap 40cc

According to Department of Health, this safety alert involved a device in Hong Kong that was produced by Jiangsu Rongye Technology Co Ltd..

What is this?

Alerts provide important information and recommendations about products. Even though an alert has been issued, it does not necessarily mean a product is considered to be unsafe. Safety Alerts, addressed to health workers and users, may include recalls. They can be written by manufacturers, but also by health officials.

Learn more about the data here
  • Type of Event
    Safety alert
  • Date
    2016-04-06
  • Event Date Posted
    2016-04-06
  • Event Country
    Hong Kong
  • Event Source
    DH
  • Event Source URL
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20160406c.html
  • Notes / Alerts
    Hong Kong data is current through September 2018. All of the data comes from the Department of Health (Hong Kong), 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 data from the U.S. and Hong Kong.
  • Extra notes in the data
    Medical Device Safety Alert
  • Reason
    Medical device safety alert: jiangsu rongye technology amed mucus trap 40cc the hospital authority (ha) of hong kong issued a press release on 5 april 2016 concerning amed mucus trap 40cc, manufactured by jiangsu rongye technology co ltd. [model number: k1023; lot number: 1503b006]. seven bronchoscopy cytology specimens, collected from 1 march 2016 among a group of patients in the medical department of ruttonjee and tang shiu kin hospital, were confirmed positive for non-viable fungus. the hospital later formed an expert panel to conduct an investigation on this issue. the panel conducted thorough investigation on the environment of the hospital, bronchoscopy appliances as well as infection control procedure to identify the root cause. the panel finally found similar non-viable fungus in the abovementioned mucus traps. to ensure patient safety, the hospitals concerned had immediately suspended the use of the affected mucus traps and followed up with the supplier for recall and substitutes from other suppliers. for details, please refer to the ha’s press release: http://www.Info.Gov.Hk/gia/general/201604/05/p201604050852.Htm if you are in possession of the affected products, please contact your supplier for necessary actions posted on 6 april 2016.

Device

AMED Mucus Trap 40cc

Manufacturer

Jiangsu Rongye Technology Co Ltd.