MONOJECT SALIVA EJECTOR
Received Nov 26, 1997 · Event occurred Oct 25, 1997
Report 1314426-1997-00025 · MDR key 134831
Device
Generic name
Saliva Ejector
Manufacturer
Sherwood Davis And GeckModel number
NACatalog number
8881-450004
Lot number
452125
Product problems
- Detachment Of Device Component
Patient
15 YR
- No Consequences Or Impact To Patient
- No Consequences Or Impact To Patient
Narrative
Additional Manufacturer Narrative
SAMPLES FROM THE SAME LOT WERE RETURNED AND EVALUATED. NO PRODUCT PROBLEMS WERE IDENTIFIED. MFG WAS ASKED TO EVALUATE THE SAMPLES. PROBLEMS WERE IDENTIFIED IN THE BOND ASSEMBLY OF LOTS PRODUCED IN THE SAME TIME FRAME. CORRECTIVE ACTION WAS LITIATED ON THE BOND EQUIPMENT. ALSO, ADD'L PRODUCTION CHECKS AND QA TESTING FOR TIP SECURITY WERE ADDED.
Description of Event or Problem
CUSTOMER REPORTED THAT ON SATURDAY 10/25/97, DURING SURGERY THE TIP CAME OFF AN EJECTOR IN THE PT'S MOUTH. THE NURSE CHECKED THE PT'S MOUTH WITH HER HAND AND COULD NOT FIND THE TIP. THE PHYSICIAN WAS ASKED TO ASSIST AND LOCATED THE TIP AT THE BACK OF THE PT'S TEETH WITH A LARYNGOSCOPE. NO INJURY WAS REPORTED.