MalfunctionDYN
450 SAL EJECTOR 3283
Received Nov 14, 2011 · Event occurred Oct 26, 2011
Report 9612030-2011-00018 · MDR key 2369421
Device
Generic name
Saliva Ejector
Manufacturer
CovidienModel number
8881450004Catalog number
8881450004
Lot number
115004164
Product problems
- Detachment Of Device Component
Patient
UNK
- No Known Impact Or Consequence To Patient
Narrative
Additional Manufacturer Narrative
SUBMIT DATE: (B)(4) 2011. AN INVESTIGATION IS CURRENTLY UNDERWAY. UPON COMPLETION, THE RESULTS WILL BE FORWARDED.
Description of Event or Problem
IT WAS REPORTED TO COVIDIEN ON (B)(6) 2011 THAT A CUSTOMER HAD AN ISSUE WITH A SALIVA EJECTOR. THE CUSTOMER REPORTS THAT THE BLUE TIP DETACHED IN THE PT'S MOUTH DURING A PROCEDURE. THE TIP WAS SUCCESSFULLY REMOVED WITH NO IMPACT OR HARM TO THE PT.