Sections a,b,d and f- information received from user facility.
Manufacturer completed to the best of the co's.
Ability.
B.
4, f.
8, and f.
11 - manufacturer submitted report to fda on this date.
F.
10 - manufacturer determined appropriate codes.
H.
6.
- evaluation codes: method: the rep from user facility, materials manager, stated that the pt involved in the event received no injury as a result of this incident.
According to rep, the blade was replaced with another deroyal blade and the procedure was completed without further incident.
The facility disposed of the broken blade; therefore, they were unable to return it to the co for evaluation.
Quality assurance manager was notified of the incident and was asked to respond to a corrective action request.
Manager reports that without having the blade in question to examine, they must assume that the apparent cause was excessive lateral pressure being excercised during the procedure.
When the blade is placed in the deroyal convenience kit, it remains in the original foil package.
Deroyal manufacturing evaluated the production process for any possible causes for this event and none were found.
The blade is positioned in the convenience kit in a way to protect it from breakage.
The blades from non-released inventory were inspected, but no defects were found.
They were also manipulated, but the failure could not be duplicated.
Without the ability to test the broken device, deroyal cannot determine the exact cause of the event.
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