Medical device manufacturer, B. Braun, has issued a medical device safety alert concerning its Certofix Quattro [Affected product in Hong Kong: Article Number: 4167775; Article Name: CERTOFIX QUATTRO V 820; Batch Number: 18H20A8551].
The affected product is a four-lumen catheter for catheterization of the superior vena cava using the Seldinger technique. Central venous catheters are well known and routinely used for central vein puncture and establishing access to the blood system of a patient to deliver infusion solutions, blood or pharmaceuticals in carrier solutions or monitoring systemic pressure.
In order to avoid accumulation of blood or fluid in the dead space between side hole and catheter tip, the lumen is closed with a plug.
According to the manufacturer, in the course of internal quality and post market surveillance activities, it found that the plug may not stay in its intended position. The deviation is caused by supplier related component quality issues.
While no serious injuries to patients, users, or third parties have been reported to date, there is a remaining risk of an undersupply, infusion of the plug into the patient and thrombus formation up to embolism. All other Certofix catheter variants (Mono, Duo, Trio, Quinto) are not affected as the lumen closure has a different design and is completely produced in-house.
Users are advised to take the following actions:
According to the local supplier, the affected products are distributed in Hong Kong.
If you are in possession of the products, please contact your supplier for necessary actions.
Posted on 14 Mar 2019