Medical device manufacturer, Bard Peripheral Vascular, Inc. (BPV), has issued a medical device safety alert concerning its Denali IVC Filter. Specific product code/lot number combinations of Denali IVC Filter are affected and the affected code numbers are as follows:
On 18 December 2015, Nordson Medical, notified BPV of an issue with the stop cock that is included in the Denali IVC filter introducer set. According to Nordson Medical, specific lots of stop cocks are at risk of having cracks in the stop cock body.
According to BPV, all assemblies including the stop cock, are 100% tested to ensure no leaks are present in the assembled device during the manufacturing process. Furthermore, BPV recently conducted simulated clinical use testing utilising product with visible cracks on the stop cock. All testing passed the criteria of not leaking. As such, BPV concluded that the cracking is superficial in nature with no impact on product performance or patient safely.
A clinical health hazard was performed by BPV considering all potential clinical issues that could arise from a crack in the indicated location. This assessment concluded that, in the worst case, if an unsuspecting user utilised a Denali IVC filter with a cracked stop cock, it is possible that a drop of fluid could form on the stop cock during flushing of the introducer or during the negative pressure associated with aspiration a small amount of air could be drawn into the syringe. In both cases, it is unlikely that the leak would be noticed by the user.
BPV is removing the affected products from the customers impacted by the Nordson recall.
According to the local supplier, the affected products are distributed in Hong Kong.
If you are in possession of the affected products, please contact your supplier for necessary actions.
Posted on 18 February 2016