Kimal plc is initiating a Field Safety Notice in regards to certain lot numbers within our Altius Central Venous Catheter range of products. The affected products have been circulated as individual Catheter Kits and included within a Procedure pack as listed below” MHRA (2017).
MHRA report “Kimal plc is initiating a Field Safety Notice in regards to certain lot numbers within our Altius Central Venous Catheter range of products. The affected products have been circulated as individual Catheter Kits and included within a Procedure pack as listed below.
The 18G Echogenic Introducer Needle included in the kit is used to perform the venepuncture, aspiration of blood and guidewire introduction and is the component affected by this Field Safety Notice.
Description of issue: Kimal plc has received customer complaints indicating that the 18G Echogenic Introducer Needle, included in these kits, is in a small number of cases, cracking during use. The reported failures have occurred during catheter insertion, when aspirating blood into the syringe to confirm correct needle placement or during infusion. During the aspiration process a crack in the hub has been observed and occasionally air bubbles have been seen in the syringe. During infusion leaks have been observed.”
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