Alerta De Seguridad para Beacon Tip Catheters

Safety alert

2016-04-27

2016-04-27

Hong Kong

DH

https://www.mdco.gov.hk/english/safety/recalls/recalls_20160427.html

Medical device safety alert: cook medical beacon tip catheters the therapeutic goods administration (tga) of australia has posted a medical device safety alert concerning beacon tip catheters [multiple products affected and multiple catalogue numbers affected], manufactured by cook medical. the manufacturer has identified an increase in reports of polymer degradation of the catheter tip, resulting in tip fracture and/or separation. the preliminary investigation has identified that environmental conditions, such as storage temperature, humidity, and the use of vaporized hydrogen peroxide (vhp) for whole-room decontamination within healthcare facilities, may be contributing to the occurrence. it is recognised that there may be other undetermined contributors to this issue and continue to investigate. potential adverse events that may occur as a result of catheter polymer degradation include loss of device function, separation of a device segment leading to medical intervention, or complications resulting from a separated segment. such complications include device fragments in the vascular system, genitourinary system, or other soft tissues. fragments within the vascular system could result in embolization to the heart or lungs, or occluding blood flow to end organs. the manufacturer is advising users to quarantine and return any unused product. according to the local supplier, the affected products are distributed in hong kong. for details, please refer to the tga website: http://apps.Tga.Gov.Au/prod/sara/arn-detail.Aspx?k=rc-2016-rn-00483-1 if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 27 april 2016.