Extract:
“BD has confirmed an increase in reports for leakage from the injection port of the BD VenflonTM Pro Safety (VPS) Needle Protected I.V. Cannula (Figure 1) to 2.5 complaints per million devices sold when sterilized by ETO (Figure 2). The identified root cause is due to a modification in the injection port valve dimensions in June 2019 to accommodate EtO sterilisation. This issue is seen primarily on the 14-18G devices with lower occurrences on alternative gauge devices.”
Reference:MHRA reference: 2021/002/018/291/010. Vascular Cannula And Catheters. Model: Venflon Pro Safety I.V. Cannula. 01 March 2021.