PERIFIX®

Additional Manufacturer Narrative

THIS REPORT HAS BEEN IDENTIFIED AS B. BRAUN MEDICAL INTERNAL REPORT NUMBER (B)(4). THE INVESTIGATION IS ONGOING AT THIS TIME. A FOLLOW UP WILL BE SUBMITTED WHEN THE INVESTIGATION RESULTS BECOME AVAILABLE.

Description of Event or Problem

AS REPORTED BY THE USER FACILITY: RESIDUE IN LIDOCAINE VIAL.

Additional Manufacturer Narrative

THIS REPORT HAS BEEN IDENTIFIED AS B. BRAUN MEDICAL INTERNAL REPORT NUMBER (B)(4). SEVERAL PHOTOS WERE PROVIDED FOR EVALUATION. VISUAL EVALUATION OF THE PHOTOS SHOWED LIDSTOCK PACKAGING FROM THE REPORTED ITEM AND LOT, AND THREE PHOTOS SHOWED AN OPENED, USED VIAL OF LIDOCAINE WITH THE LOT AND NDC NUMBERS, WITH SOME YELLOWISH SPOTS OF AN UNKNOWN SUBSTANCE. ALTHOUGH SOME RESIDUE WAS SEEN ON THE VIAL, THE PHOTOS DO NOT CONFIRM THIS TO BE THE RESULT OF ANY MANUFACTURING PROCESS OR SUPPLIER ISSUE. RETAINED UNITS WERE EVALUATED AND PASSED THE INTERNAL TESTING. SINCE A SAMPLE WAS NOT RETURNED FOR EVALUATION, THE EXACT ROOT CAUSE OF THIS INCIDENT COULD NOT BE DETERMINED. A REVIEW OF THE DEVICE HISTORY RECORD (DHR) WAS PERFORMED FOR THE REPORTED LOT NUMBER AND NO ABNORMALITIES OR NONCONFORMANCES WERE NOTED DURING THE IN PROCESS OR FINAL PRODUCT INSPECTION. WE WILL MAINTAIN THIS REPORT FOR FURTHER REFERENCES AND CONTINUE TO MONITOR OTHER REPORTS FOR SIMILAR OCCURRENCES. IF ANY ADDITIONAL PERTINENT INFORMATION BECOMES AVAILABLE, A FOLLOW UP WILL BE SUBMITTED.