MalfunctionHTT
4.0MM 12 FLUTE BARREL BUR - HOLLOW, FORMULA (5BX)
Received Aug 31, 2010 · Event occurred Aug 13, 2010
Report 2648666-2010-00374 · MDR key 1826689
Device
Product problems
- Tear, Rip or Hole in Device Packaging
Patient
UNK
- No Patient Involvement
Narrative
Additional Manufacturer Narrative
ADD'L INFO WILL BE PROVIDED ONCE THE INVESTIGATION IS COMPLETED.
Description of Event or Problem
IT WAS REPORTED THAT WHEN THE NURSE OPENED THE BOX OF PRODUCT DURING PREPARATION FOR USE, A SMALL HOLE WAS NOTICED IN THE STERILE BARRIER OF THE PACKAGING. IT WAS FURTHER REPORTED THAT ANOTHER BOX OF PRODUCT WAS AVAILABLE FOR USE. THERE WAS NO PATIENT INVOLVEMENT AND THUS NO ADVERSE CONSEQUENCES.