Medical Devices Alerts issued in July 2019

Alerts were issued about Telefunken automated external defibrillators and BD Microtainer capillary blood specimen collection tubes.

In this monthly update, we highlight selected Medical Device Alerts that have been issued recently by MHRA. Please note, this is not an exhaustive list of medical device alerts. For all Medical Device Alerts from MHRA, see Alerts and recalls for drugs and medical devices.

Automated external defibrillators: All Telefunken HR1 & FA1 – no valid CE certificate (MDA/2019/027). Issued 25 July 2019. Manufactured by Defiteq International BV or GGT Holding BV. The safety and performance of these devices cannot be verified, and their safe use can no longer be assured. It is recommended that organisations initiate a process to source an alternative defibrillator.

Professional use capillary blood specimen collection: BD Microtainer tubes – risk of blood leakage and/or incorrect test results due to defective tubes. Issued 24 July 2019. Manufactured by Becton Dickinson (BD). Tubes may contain a hole or be damaged or deformed, potentially causing blood leakage and/or an inadequate blood-to-additive ratio, leading to incorrect test results. In these cases, re-sampling could lead to a delay in treatment. It is recommended to inspect inventory for the devices listed in the notice and return or destroy any device affected.

Article citation: Drug Safety Update volume 13, issue 1: August 2019: 5.

Published 19 August 2019