InjuryOGW
SMITHS MEDICAL BLUE LINE ULTRA TRACHEOSTOMY KIT
Received Apr 24, 2019 · Event occurred Dec 4, 2018
Report 3012307300-2019-02251 · MDR key 8545274
Device
Generic name
Tracheostomy
Manufacturer
Smiths Medical Asd, Inc.Catalog number
100/800/075CZ
Lot number
3484641
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 UNDER LOCAL ANESTHESIA FOR CEREBRAL INFARCTION, WAS USING A SMITHS MEDICAL TRACHEAL TUBE KIT. IT WAS REPORTED THAT PATIENT'S WOUND WAS OOZING AND AIR LEAKS WERE NOTED IN THE BALLOON. THE TUBE WAS REPLACED IMMEDIATELY.