MalfunctionDYN
SALIVA EJECTORS
Received Jan 16, 1998
Report 1314426-1998-00003 · MDR key 144429
Device
Generic name
Saliva Evacuation Device
Manufacturer
Sherwood Davis And GeckModel number
NACatalog number
8881-450004
Lot number
452125
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 THAT TIPS ARE COMING OFF THE EJECTORS. ALL TIPS CAME OFF IN PT'S MOUTHS. THEY WERE REMOVED SUCCESSFULLY BY THE DR OR NURSE EITHER MANUALLY OR WITH HEMOSTATS. NO INJURY WAS REPORTED.
Additional Manufacturer Narrative
PROBLEMS WERE IDENTIFIED IN THE BOND ASSEMBLY OF LOTS PRODUCED IN THE SAME TIME FRAME. CORRECTIVE ACTION WAS INITIATED ON THE BOND EQUIPMENT. ALSO, ADDITIONAL PRODUCTION CHECKS AND QA TESTING FOR TIP SECURITY WERE ADDED.