450 SAL EJECTOR 3283
Received Aug 28, 2012 · Event occurred Aug 3, 2012
Report 9612030-2012-00044 · MDR key 2722653
Device
Generic name
Saliva Ejector
Manufacturer
CovidienModel number
8881450004Catalog number
8881450004
Lot number
UNKNOWN
Product problems
- Detachment Of Device Component
Patient
UNKNOWN
- No Consequences Or Impact To Patient
Narrative
Description of Event or Problem
IT WAS REPORTED TO COVIDIEN ON (B)(6) 2012 THAT A CUSTOMER HAD AN ISSUE WITH A SALIVA EJECTOR. THE CUSTOMER STATES DURING USE ON A PT, THE BLUE TIP DETACHED. THERE WAS NO PT HARM. PER THE REPORTER, A CANNULATION TUBE WAS USED ON THE PT AND THE TUBE WAS FIXED WITH A BITE BLOCK . IN ORDER TO PROVIDE ORAL CARE FOR THE PT, A SALIVA EJECTOR WAS INSERTED BETWEEN THE TUBE AND BITE BLOCK. THE BLUE TIP WAS SLIGHTLY STUCK IN THE BITE BLOCK, THEN THE BLUE TIP FELL OFF INSIDE THE PT'S MOUTH. IT DID NOT GO INTO THE PT'S THROAT. THE BITE BLOCK WAS DETACHED FROM THE PT AND THE BLUE TIP WAS REMOVED FROM THE PT'S MOUTH.
Additional Manufacturer Narrative
(B)(4). AN INVESTIGATION IS CURRENTLY UNDERWAY. UPON COMPLETION, THE RESULTS WILL BE FORWARDED.