Events

Avis De Sécurité sur MiniCap-Disconnect Cap

Selon ALIMS (Agencija za lekove i medicinska sredstva), ce/cet/cette avis de sécurité concerne un dispositif en/au/aux/à Serbia qui a été fabriqué par BAXTER HEALTHCARE.

Qu'est-ce que c'est?

Les avis de sécurité sont des communications que les fabricants de dispositifs médicaux ou leurs représentants font parvenir en particulier aux travailleurs du secteur médical, mais aussi aux utilisateurs de ces dispositifs. Les avis de sécurité concernent les actions entreprises quant aux dispositifs présents sur le marché et peuvent inclure des rappels et des alertes.

En savoir plus sur les données ici
  • Type d'événement
    Field Safety Notice
  • Date
    2015-06-02
  • Date de publication de l'événement
    2015-11-02
  • Pays de l'événement
    Serbia
  • Source de l'événement
    ALIMSA
  • URL de la source de l'événement
    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/
  • Notes / Alertes
    Serbian data is current through February 2018. All of the data comes from ALIMS (Agencija za lekove i medicinska sredstva), except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Serbia.
  • Notes supplémentaires dans les données
  • Cause
    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.

Device

MiniCap-Disconnect Cap
  • Modèle / numéro de série
    SPC4466 - 14B23H15; BEPC4466 - 13J23H15
  • Manufacturer
    BAXTER HEALTHCARE

Manufacturer

BAXTER HEALTHCARE