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: DURING THE PROCEDURE, THE DISTAL END OF THE NEEDLE SEPARATED AND REMAINED IN THE PATIENT. ULTRASOUND GUIDANCE WAS USED TO LOCATE AND RETRIEVE THE FRAGMENT SUCCESSFULLY.

Additional Manufacturer Narrative

THIS REPORT HAS BEEN IDENTIFIED AS B. BRAUN MEDICAL INTERNAL REPORT NUMBER (B)(4). NO SAMPLE WAS PROVIDED; HOWEVER, ONE (1) PHOTOGRAPH WAS SUBMITTED FOR EVALUATION. VISUAL EXAMINATION OF THE PHOTOGRAPH SHOWED A USED, CONTAMINATED NEEDLE IN WHAT APPEARED TO BE A PLASTIC CUP BUT DID NOT CONFIRM THE BREAKAGE. BASED ON VISUAL FINDINGS, THE PROVIDED PHOTOGRAPH DID NOT PROVIDE SUFFICIENT EVIDENCE TO CONFIRM THE DEFECT REPORTED. B BRAUN KITS ARE PACKAGED ACCORDING TO BLUEPRINT SPECIFICATIONS WHILE INSPECTING FOR ANY DEFECTS OR DEVIATIONS FROM DRAWING (E.G. EMBEDDED PARTICLES, DIRT, MISSING OR INCORRECTLY ASSEMBLED PARTS, ETC.). IN ADDITION, THERE ARE INCOMING, IN PROCESS AND FINAL FUNCTIONAL INSPECTIONS PERFORMED DURING THE MANUFACTURING OF COMPONENTS AND FINISHED GOOD ITEMS. 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. 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.