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IV extension sets with multiple ports and vented caps

BfArM-Ref.: 2666/12

According to information available to BfArM, several manufacturers are distributing IV extension sets with multiple ports that are provided with vented caps due to manufacturing requirements. Usually, according to manufacturers' information, these vented caps have to be exchanged with non-vented caps by users before use. Otherwise, air ingress could possibly lead to air embolism. In case the caps are not recognised to users as vented caps, an exchange may remain undone.

BfArM recommends users to comply with the IFU of the devices and to check the tubing sets before use. Additionally, we recommend to contact manufacturers and suppliers to obtain additional information on the safe use of the devices. If applicable, vented caps have to be exchange with non-vented caps prior to their use. Where appropriate, devices with non-vented caps should be considered.

Manufacturers should ensure that their devices can be used safely within their intended use. Devices must conform to safety principles, taking account of the generally acknowledged state of the art. From BfArM's point of view, this includes an integration of non-vented caps wherever possible, or, if applicable, a clear labelling (including the IFU) of the devices.

The British competent Authority MHRA has previously informed about this risk (MDA /2010/068).

In case of questions please contact:

Federal Institute for Drugs and Medical Devices
Medical Devices Division
Kurt-Georg-Kiesinger-Allee 3
53175 Bonn
Facsimile: +49 (228) 207-5300

Phone: +49 (228) 207-5382 (non-active medical devices)
Phone: +49 (228) 207-5384 (active medical devices and medical technology)
Phone: +49 (228) 207-5360 (in vitro diagnostics)