PENCAN®

Description of Event or Problem

ACCORDING TO THE EVENT DESCRIPTION: "DURING THE PUNCTURE PROCEDURE, THE NEEDLE BROKE WITHOUT ANY APPARENT CAUSE, DESPITE NO MISUSE OR EXCESSIVE FORCE BEING APPLIED. A FRAGMENT APPROXIMATELY FIVE CENTIMETERS IN LENGTH REMAINED LODGED IN THE PATIENT'S MUSCLE."

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.