PORTEX MINI-TRACH II - NON SELDINGER KIT

Description of Event or Problem

INFORMATION WAS RECEIVED INDICATING THAT FOLLOWING PUNCTURE OF THE PATIENT, THE SALINE FILLED SYRINGE TO A SMITHS MEDICAL MINI-TRACH II SELDINGER 4.0MM CRICOTHYROIDOTOMY KIT, COULD NOT BE PULLED BACK. IT WAS NOTED THAT THE NEEDLE HAD BEEN CLOGGED BUT HAD INITIALLY SUCKED AIR FOLLOWING ATTACHMENT OF THE SYRINGE. THERE WERE NO REPORTED ADVERSE EFFECTS.

Additional Manufacturer Narrative

THE MENTIONED SHORT TUOHY NEEDLE WAS SHIPPED TO THE SMITHS MEDICAL SITE CUMBERNAULD AS BULK COMPONENT AND USED FOR PRODUCING THE FINISHED GOOD. VISUAL INSPECTION HAS FOUND A PARTICLE IN THE NEEDLE. THE ORIGIN OF THIS PARTICLE COULD NOT BE DETERMINED, AS NO DEVIATIONS IN THE INSPECTION PROTOCOL OF THE INVOLVED NEEDLE LOT HAD OCCURRED. THE REPORTED COMPLAINT WAS CONFIRMED, HOWEVER THIS INVESTIGATION REVEALED NO INTRINSIC EVIDENCE TO SUGGEST A ROOT CAUSE RELATED TO MANUFACTURING.