PENCAN®

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: INCIDENT_DESCRIPTION LORS DE L'ANESTHÉSIE RACHIDIENNE, IL Y A EU CONTACT OSSEUX AVEC L'AIGUILLE ET LORS DU RETRAIT POUR SE REPOSITIONNER, DÉCOUVERTE QUE L'AIGUILLE EST BRISÉE EN DEUX. LE BOUT DE L'AIGUILLE SPINALE A DÛ ÊTRE RETIRÉ CHIRURGICALEMENT. TRANSLATION: DURING THE SPINAL ANESTHESIA, THERE WAS BONE CONTACT WITH THE NEEDLE AND UPON WITHDRAWAL TO REPOSITION, IT WAS DISCOVERED THAT THE NEEDLE WAS BROKEN IN TWO. THE TIP OF THE SPINAL NEEDLE HAD TO BE SURGICALLY REMOVED.

Additional Manufacturer Narrative

THIS REPORT HAS BEEN IDENTIFIED AS B. BRAUN MEDICAL INTERNAL REPORT NUMBER (B)(4). A REVIEW OF THE DISCREPANCY MANAGEMENT SYSTEM (DSMS) DATABASE WAS PERFORMED FOR THE REPORTED LOT NUMBER AND NO ABNORMALITIES OR NON-CONFORMANCES WERE NOTED DURING THE IN PROCESS OR FINAL PRODUCT INSPECTION. FIVE RETAINS FROM THE REPORTED LOT NUMBER WERE TESTED AND PASSED PER SPECIFICATION. NO SAMPLE WAS PROVIDED FOR EVALUATION. BASED ON THE DATA FROM THE INVESTIGATION, THE ROOT CAUSE OF THE REPORTED INCIDENT WAS UNABLE TO BE DETERMINED. THE REPORTED DEFECT WAS UNABLE TO BE CONFIRMED. 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.