MalfunctionEID
COMPULE SYRINGE (COMPULES TIPS GUN)
Received Nov 26, 2002
Report 2515379-2002-00055 · MDR key 430673
Device
Generic name
Restorative Dispensing Syringe
Manufacturer
Dentsply CaulkModel number
NACatalog number
635105
Lot number
UNK
Product problems
- Fracture
- Tip breakage
Patient
UNKNOWN
- No Consequences Or Impact To Patient
Narrative
Description of Event or Problem
DR ALLEGED THAT WHILE USING A COMPULE TIP APPLICATOR GUN, THE TIP (WHICH THE COMPULE SNAPS INTO) FRACTURED WITH A LOUD BANG WHEN PRESSURE WAS APPLIED TO THE HANDLE. A FRAGMENT OF PLASTIC WAS PROPELLED ACROSS THE ROOM. NO ONE WAS INJURED. A SECOND GUN ALSO FRACTURED IN USE WHERE THE NOZZLE JOINS THE BODY OF THE DEVICE.