UK regulatory authority the MHRA has issued a Medical Device Alert (MDA) pertaining to the Neria Steel Cannula Infusion Set manufactured by Unomedical. Apparently there is a risk of needle breakage in use, leading to leakage of medication, and the potential need for surgical intervention to remove needle.
The Unomedical infusion devices business is a subsidiary of Convatec.
Unomedical’s Neria infusion sets are intended for continuous subcutaneous infusion of medication, particularly in the treatment of Parkinson’s disease, primary immune deficiency, and thalassaemia. These sets are not intended for use in the treatment of diabetes or in palliative care, though their use in these clinical areas is known.
The MHRA’s MDA can be found here in full.
Action required by personnel involved in the use of these devices includes ensuring awareness of the potential for the needle to break, along with a set of procedures for users including patients which include checking the infusion sets prior to use (to identify and avoid using sets with bent or damaged needles). Furthermore users are guided to remove sets carefully and check that they are intact after use, make sure they have received and understood the instructions for use and ultimately contact a health care provider for clinical assessment if a needle has broken off.
The MDA pertains to a range of sets (listed on the attachment), with expiry dates up to and including January 2017.