inforMED
MalfunctionBTO

JET VENTILATION CATHETER 13G

Received Jun 23, 2010

Report 8010939-2010-00002 · MDR key 2523084

Device

Generic name

None

Model number

30-02-013-1

Lot number

20068

Product problems

  • Occlusion Within Device
  • Material Twisted/Bent

Patient

Not reported

  • Extubate

Narrative

Description of Event or Problem

THE INNER CATHETER IS REMOVED FROM THE OUTER HUB AFTER INSERTION INTO PT AND DURING THE DISCONNECTION OF THE LUER LOCK CONNECTION. THE INNER CATHETER TWISTED AND OCCLUDED MEANING THAT NO GAS COULD PASS THROUGH THE CATHETER INTO THE PTS LUNGS. THEREFORE PT WAS VENTILATED BY BAG AND MASK, CATHETER REMOVED AND REPLACED UNDER ANESTHETIC BY ONE FROM A DIFFERENT BATCH NUMBER. OPERATION PROCEEDED AND CONCLUDED UNEVENTFULLY.

Remedial action

  • Replace