ESPOCAN®

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. 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

ACCORDING TO THE EVENT DESCRIPTION: "DURING THERAPY - DURING THE PROCEDURE PART OF CATHETER WAS CUT AND REMAINED IN EPIDURAL SPACE".

Additional Manufacturer Narrative

THIS REPORT HAS BEEN IDENTIFIED AS B. BRAUN MEDICAL INTERNAL REPORT NUMBER (B)(4). COMPLAINT PROCESSING DEPARTMENT RECEIVED ONE CUSTOMER PICTURE OF ESPOCAN + DS+PST+PENC 0.42X138,5MM 27G. THE FOLLOWING INVESTIGATIONS WERE CONDUCTED: THE SAMPLE AT THE CUSTOMER PICTURE WAS TAKEN TO A VISUAL INSPECTION FOR DAMAGES ACCORDING TO TEST METHOD 102002_DAMAGES. THE CUSTOMER PICTURE SHOWS AN ORIGINAL PACKED ESPOCAN + DS+PST+PENC 0.42X138,5MM 27G. A CUT-OFF CATHETER, AS DESCRIBED BY THE CUSTOMER, WAS NOT DETECTED ON THE CUSTOMER PICTURE. THEREFORE AN EVALUATION OF THE COMPLAINT DUE TO THE RECEIVED CUSTOMER PICTURE IS NOT POSSIBLE FOR COMPLAINT PROCESSING DEPARTMENT. AS NO SAMPLE AND NO MEANINGFUL PICTURE WAS PROVIDED FOR INVESTIGATION A MALFUNCTION COULD NOT BE DETECTED AND THEREFORE THE DEFECT IS CONSIDERED AS NOT CONFIRMED. 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.