SALIVA EJECTORS
Received Jan 16, 1998
Report 1314426-1998-00002 · MDR key 144425
Device
Generic name
Saliva Evacuation Device
Manufacturer
Sherwood Davis And GeckModel number
NACatalog number
8881-450004
Lot number
UNK
Product problems
- Detachment Of Device Component
Patient
UNKNOWN
- No Consequences Or Impact To Patient
- Foreign body, removal of
Narrative
Description of Event or Problem
CUSTOMER REPORTS THE TIPS OF THE SALIVA EJECTORS COME OFF IN THE PT'S MOUTHS. THE TIPS WERE REMOVED WITHOUT INCIDENT. NO INJURY IS REPORTED.
Additional Manufacturer Narrative
FOLLOW-UP REPORT STATED NO SAMPLES WERE RETURNED WITH THIS COMPLAINT. THIS WAS AN INCORRECT STATEMENT. ONE HUNDRED ONE SAMPLES WERE RETURNED AND EVALUATED AS STATED IN INITIAL & FOLLOW-UP #1.
Additional Manufacturer Narrative
NO SAMPLES WERE RETURNED WITH THIS COMPLAINT; HOWEVER, SAMPLES WERE RETURNED BY THE CUSTOMER FOR A SIMILAR COMPLAINT. 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 QA TESTING FOR TIP BOND SECURITY.