MalfunctionDYN
450 SAL EJECTOR 3283
Received Mar 14, 2012
Report 9612030-2012-00020 · MDR key 2512349
Device
Generic name
Saliva Ejector
Manufacturer
CovidienModel number
8881450004Catalog number
8881450004
Lot number
UNK
Product problems
- Detachment Of Device Component
Patient
UNK
- No Consequences Or Impact To Patient
Narrative
Additional Manufacturer Narrative
SUBMIT DATE: (B)(4) 2012. 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) 2012 THAT A CUSTOMER HAD AN ISSUE WITH A SALIVA EJECTOR. THE CUSTOMER REPORTS THAT A PT WAS HAVING AN EGD AND BEING SUCTIONED BY ONE OF OUR ANESTHESIOLOGISTS AND THE BLUE PART ON THE TIP CAME OFF THE TUBE AND LODGED INTO THE PT'S MOUTH. THE CUSTOMER REPORTS THAT THEY WERE ABLE TO PULL IT OUT WITH FORCEPS. THE CUSTOMER REPORTS THE PT STATUS IS FINE.