Medical devices and equipment are items used for the diagnosis and/or treatment of disease, for monitoring patients, and as assistive technology. Medical Device Alerts (MDAs) are the MHRA's prime means of communicating safety information to medical device users in health and social care.
Below are the MDAs we have published that are of particular relevance to pharmacists. To see a complete list of our MDAs, please visit the Medical Device Alert section of our website.
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17 May 2012 | Medical Device Alert: Clever Chek blood glucose monitoring system distributed by BBI Healthcare (MDA/2012/027)
This Medical Device Alert has been issued as the MHRA has been informed that there is potential for falsely low blood glucose results if the test strips are under-filled, and falsely high results if over-filled when using Clever Chek blood glucose monitoring system distributed by BBI Healthcare. This could result in inappropriate insulin administration.
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17 May 2012 | Class 3 Drug Alert (Action Within 5 days): Kappin Limited - Fulsovin 125mg/5ml Oral Suspension - EL (12)A/19
Kappin Limited is recalling all remaining stock of this product because stability testing has indicated that the product will not comply with the required specifications for the duration of the shelf-life.
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15 Jun 2011 | Medical Device Alert: Needle-free intravenous connectors. All manufacturers (MDA/2011/068)
This Medical Device Alert has been issued due an incompatibility of some pre-filled glass syringes with various needle-free connectors and a possible risk of infection and/or air embolus to patients when an adaptor remains attached to a needle-free connector after use.
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07 Jun 2011 | Medical Device Alert: Alcohol skin preparation pads, swabs and swabsticks manufactured by Triad Group Inc since 2007 (MDA/2011/065)
This Medical Device Alert has been issued because the manufacturers published Field Safety Notices (FSN) for these devices in April 2011, but have not had sufficient confirmation from users that they have received and acted on this information.
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26 May 2011 | Medical Device Alert: Enteral feeding pump: Applix Smart and Applix Vision Nutrition pumps. Manufactured by Fresenius Kabi (MDA/2011/058)
This Medical Device Alert has been issued because there is a risk of under-delivery of enteral feed with the affected products.
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19 May 2011 | Medical Device Alert: Dermabond® (product code AHV12) and Dermabond™ Mini (product code AHVM12) - topical skin adhesive, manufactured by Ethicon Products, J&J Medical Ltd (MDA/2011/052)
This Medical Device Alert has been issued as there have been reports that some units contained discoloured products in the vial and may have had prolonged setting times.
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13 Apr 2011 | Medical Device Alert: Alaris® infusion sets manufactured by Carefusion (MDA/2011/036)
This Medical Device Alert has been issued due to a potential for leakages and/or set disconnections in devices from specific lots.
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07 Apr 2011 | Medical Device Alert: Optilube lubricating jelly manufactured by Optimum Medical Solutions (MDA/2011/033)
This Medical Device Alert has been issued as part of a specified lot number was found to be non-sterile and contaminated with the yeast Candida guilliermondi, which can cause infection in patients that may be immunocompromised and those with malignancy.
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17 Mar 2011 | Medical Device Alert: Microlance 30G x ½” sterile hypodermic needle manufactured by BD Medical (MDA/2011/028)
This Medical Device Alert has been issued as these needles, used for a variety of clinical procedures, may be blocked or partially blocked.
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03 Mar 2011 | Medical Device Alert: Alcohol skin preparation pads, swabs, and swabsticks manufactured by Triad Group Inc for H&W cv since 2007 (MDA/2011/023)
This Medical Device Alert has been issued because of a potential bacterial contamination of alcohol swabs which may lead to skin infection. This MDA updates MDA/2011/013R with details of additional manufacturers’ device packs and kits that contain the affected swabs.
