TOOTH CONDITIONER GEL SYRINGE
Received Sep 25, 2002
Report 2515379-2002-00042 · MDR key 418841
Device
Generic name
Dental Tooth Conditioner
Manufacturer
Dentsply CaulkModel number
NACatalog number
646125
Lot number
0012182
Product problems
- Nonstandard Device
Patient
NA
- Unknown (for use when the patient's condition is not known)
Narrative
Description of Event or Problem
THE COMPLAINT COULD NOT BE REPRODUCED WHEN RETURN SAMPLES (WHERE PROVIDED) AND/OR RETAIN SAMPLES WERE EVALUATED. THEREFORE, CO DID NOT POSITIVELY IDENTIFY ANY FAILURE MODE OR MECHANISM.
Description of Event or Problem
THE MATERIAL DRIED OUT IN THE SYRINGE.
Description of Event or Problem
TIPS WERE ATTACHED TO THE SYRINGES AND THE SYRINGES WERE THEN EXTRUDED. THERE IS NO FORMALLY DOCUMENTED METHOD FOR THIS EXTRUSION TEST; IT IS GENERALLY ASSOCIATED WITH APPEARANCE METHOD GM-062-89.
Description of Event or Problem
SINCE THE ALLEGED DEFECT COULD NOT BE REPRODUCED INTERNALLY, CO'S CONCLUSION IS THAT THE DOCTOR DID NOT PROPERLY ATTACH THE TIP TO THE FILLED SYRINGE. ALSO, THE DIRECTIONS FOR USE STATE "GEL SHOULD FLOW FREELY WITH GENTLE PRESSURE. DO NOT USE EXCESSIVE FORCE. IF NOT , REMOVE SYRINGE FROM PT FIELD AND CHECK FOR OBSTRUCTION." FAILURE TO FOLLOW THESE INSTRUCTIONS COULD LEAD TO THE COMPLAINTS OF TIPS COMING OFF. THE DIRECTIONS FOR USE ALSO STATE TO "DISCARD NEEDLES AFTER USE, AS NEEDLES MAY CLOG IF GEL IS ALLOWED TO DRY INSIDE." CLOGGED TIPS COULD CREATE THE NEED FOR EXCESSIVE FORCE, LEADING TO POTENTIAL FAILURE.