inforMED
MalfunctionOGP

MINI-TRACH II SELDINGER 4.0MM CRICOTHYROIDOTOMY KIT

Received Dec 6, 2018 · Event occurred Nov 1, 2018

Report 3012307300-2018-08564 · MDR key 8140005

Device

Generic name

Cricothyrotomy Kit

Catalog number

100/461/000

Lot number

3053047

Product problems

  • Activation, Positioning or Separation Problem
  • Activation, Positioning or Separation Problem

Patient

Not reported

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

Narrative

Additional Manufacturer Narrative

REPORT SOURCE: (B)(6).

Description of Event or Problem

INFORMATION WAS RECEIVED THAT A SMITHS MEDICAL TRACHEOSTOMY TUBE WAS BENT, MAKING IT DIFFICULT TO SECURE THE AIRWAY.