Events

Field Safety Notices about MiniCap-Disconnect Cap

According to ALIMS (Agencija za lekove i medicinska sredstva), this field safety notices involved a device in Serbia that was produced by BAXTER HEALTHCARE.

What is this?

Field safety notices are communications sent out by medical device manufacturers or their representatives in relation to actions that they may be taking in relation to their product that is on the market. These are mainly for health workers, but also for users. They can include recalls and alerts.

Learn more about the data here
  • Type of Event
    Field Safety Notice
  • Date
    2015-06-02
  • Event Date Posted
    2015-11-02
  • Event Country
    Serbia
  • Event Source
    ALIMSA
  • Event Source URL
    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 / Alerts
    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.
  • Extra notes in the data
  • Reason
    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
  • Model / Serial
    SPC4466 - 14B23H15; BEPC4466 - 13J23H15
  • Manufacturer
    BAXTER HEALTHCARE

Manufacturer

BAXTER HEALTHCARE