Important Safety Alerts

Important Safety Alerts

Medical Device Safety Alert: Jiangsu Rongye Technology AMED Mucus Trap 40cc

06 Apr 2016

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

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