MiniCap-Disconnect Cap 에 대한 현장 안전성 서한

Field Safety Notice

2015-06-02

2015-11-02

Serbia

ALIMSA

https://www.alims.gov.rs/latin/2015/02/11/obavestenje-o-meri-povlacenja-sa-trzista-medicinskog-sredstva-minicap-disconnect-cap-model-spc4466-kapica-za-transfer-set-za-peritonealnu-dijalizu/

Due to the fact that the manufacturer has recently received complaints from users stating that the sponge soaked with a povidone-iodine solution is completely separated from the cap, partially protruding from the cap, or even missing. using a minicap product that is damaged or missing a sponge with povidone-iodine may compromise the ability of the product to provide a sterile protective barrier at the end of the inter-catheter when the patient undergoes dialysis. this can cause an increased risk of peritonitis. then, using minicap products where the sponge partially protrudes from the cap may encourage improper aseptic technique, such as accidentally touching the sponge to move inside the cap. this can cause an increased risk of peritonitis. the manufacturer notes that there have been no reported adverse events regarding this product series.