SALIVA EJECTORS
Received Oct 16, 1997 · Event occurred Aug 5, 1997
Report 1314426-1997-00018 · MDR key 126654
Device
Generic name
Saliva Ejector
Manufacturer
Sherwood Davis And GeckModel number
NACatalog number
8881-450004
Lot number
UNK
Product problems
- Tip breakage
Patient
UNKNOWN
- Foreign body, removal of
Narrative
Additional Manufacturer Narrative
FIVE SAMPLES WERE RETURNED FOR EVALUATION. THE SAMPLES WERE CHECKED FOR DAMAGE, MISSING TIPS AND SECURITY OF ATTACHMENT. NO PROBLEMS WERE FOUND. CO WAS UNABLE TO CHECK THE LOT HISTORY AS NO LOT INFO WAS PROVIDED. DUE TO SIMILAR COMPLAINTS, THE MFG PLANT INSTITUTED ADDITIONAL PRODUCTION CHECKS, AND INCREASED THE QA TESTING FOR TIP BOND SECURITY.
Description of Event or Problem
CUSTOMER REPORTED, ON 08-05-97 A CRNA SUCTIONED A PT'S ORAL CAVITY WITH A SALIVA EJECTOR. UPON REMOVING THE SUCTION, SHE NOTED THAT THE BLUE TIP WAS MISSING FROM THE EJECTOR. ANESTHESIOLOGIST WAS CALLED TO THE ROOM. THE PT HAD REMAINED INTUBATED WITH THE CUFF INFLATED. THE DR WAS ABLE TO EXTRACT THE BLUE TIP OF THE EJECTOR USING A LARYNGOSCOPE AND MCGILL FORCEP.