inforMED
InjuryOGW

SMITHS MEDICAL BLUE LINE ULTRA TRACHEOSTOMY KIT

Received Apr 24, 2019 · Event occurred Mar 18, 2019

Report 3012307300-2019-02227 · MDR key 8545277

Device

Generic name

Tracheostomy

Catalog number

11/810/080CZ

Lot number

3615719

Product problems

  • Leak/Splash
  • Leak/Splash

Patient

Not reported

  • No Known Impact Or Consequence To Patient
  • No Known Impact Or Consequence To Patient

Narrative

Description of Event or Problem

INFORMATION WAS RECEIVED THAT WHILE A PATIENT WAS UNDER LOCAL ANESTHESIA, A SMITHS MEDICAL TRACHEAL TUBE KIT WAS USED. WHEN THE BALLOON AIR BAG CUTTING KIT WAS IMPLANTED, THE AIR BAG WAS FOUND TO BE LEAKING, AND A NEW TRACHEAL KIT WAS IMMEDIATELY REPLACED.