Aspen surgical received a report from the distributor indicating that a bard-parker blade was broken.
The incident occurred at the user facility.
No sample was returned.
Photographic evidence and a manufacturing lot number was provided for review.
A review of the device history record indicated no non-conformance's related to the reported issue.
The most probable root cause could have been during the stamping or grinding process.
Packaging process has established controls to mitigate broken or cracked blade condition, including a "medio" blade sensor that inspects 100% of packed pouches liner level prior to aluminum foil packaging.
The following controls are in-place to mitigate "broken blade" condition at aspen surgical (b)(4) site: heat treatment in-process at the beginning and end of each lot are inspected for dimension integrity using a pin gauge, flatness gauge and perforation length gauge, ductility test, and hardness test.
Heat treatment quality inspections at the beginning and end of each lot are inspected for dimension integrity using a pin gauge, flatness gauge and perforation length gauge, ductility test, and hardness test.
Sample was not returned.
However if sample becomes available and any additional relevant information is identified, the additional relevant information will be submitted in a supplemental report.
|