inforMED
MalfunctionBTC

PORTEX

Received Dec 30, 2021 · Event occurred Nov 1, 2021

Report 3012307300-2021-13523 · MDR key 13122196

Device

Generic name

Tracheostomy Tube

Model number

101/870/070CZ

Product problems

  • Detachment of Device or Device Component
  • Detachment of Device or Device Component

Patient

Unknown

  • No Clinical Signs, Symptoms or Conditions
  • No Clinical Signs, Symptoms or Conditions

Narrative

Description of Event or Problem

IT WAS REPORTED THAT AFTER THE USE OF THE PRODUCT, THE PILOT BALLOON GOT DETACHED. THE CUSTOMER STATED THIS HAPPENED WITHOUT CONTACT WITH SHARP OBJECTS OR APPLIED PRESSURE. NO PATIENT INJURY WAS REPORTED.