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. NOTE: THIS REPORTED 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. PLEASE NOTE, THIS DEVICE IS DISTRIBUTED OUTSIDE THE US AND NO GUDID INFORMATION EXISTS.

Description of Event or Problem

ACCORDING TO THE EVENT DESCRIPTION: "THE SPINAL TROCAR BREAKS DURING THE PROCEDURE TO INSERT IT INTO THE SPINAL SPACE, LEAVING 60 MM OF THE TROCAR INSIDE THE PATIENT. IT IS EXAMINED BY A SPECIALIST DOCTOR, WHO ADVISES AGAINST REMOVING THE FOREIGN BODY TO AVOID PROCEDURAL RISKS."