CONTIPLEX

Additional Manufacturer Narrative

THIS REPORT HAS BEEN IDENTIFIED AS B. BRAUN MELSUNGEN AG INTERNAL REPORT # (B)(4). NO SAMPLE HAS BEEN RETURNED FOR INVESTIGATION. WITHOUT THE ACTUAL SAMPLE, A THOROUGH INVESTIGATION COULD NOT BE PERFORMED AND NO SPECIFIC CONCLUSION CAN BE DRAWN AS TO THE CAUSE OF THE REPORTED EVENT. AFTER CHECKING THE RESPECTIVE DOCUMENTATION OF THE PRODUCTION (SHIFT PROTOCOL, RESULTS OF SELF-CONTROL AND IN-PROCESS CONTROL OF THE WORKERS, MACHINE DOCUMENTATION, CLEANING PROTOCOL, ETC.), NO DEVIATIONS WERE FOUND IN THE PERIOD MENTIONED. IF THE SAMPLE AND OR ADDITIONAL PERTINENT INFORMATION BECOMES AVAILABLE, A FOLLOW UP REPORT WILL BE SUBMITTED. NOTE: THIS REPORT IS BEING FILED FOR AN ITEM NUMBER THAT IS NOT SOLD IN THE UNITED STATES; HOWEVER, SIMILAR ITEMS ARE SOLD IN THE UNITED STATES BY B. BRAUN MEDICAL, INC.

Description of Event or Problem

AS REPORTED BY THE USER FACILITY (TRANSLATION OF USER FACILITY INFORMATION BY BBM SALES ORGANIZATION IN (B)(6)): CATHETER TIP LEFT IN A PATIENT.