PERIFIX®

Additional Manufacturer Narrative

THIS REPORT HAS BEEN IDENTIFIED AS B. BRAUN MEDICAL INTERNAL REPORT NUMBER (B)(4). COMPLAINT PROCESSING DEPARTMENT RECEIVED NO SAMPLE AND NO PICTURE AND THUS A FURTHER EVALUATION AND INVESTIGATION OF THE COMPLAINT WAS NOT POSSIBLE. AS NO SAMPLE AND NO PICTURE WAS PROVIDED FOR INVESTIGATION A MALFUNCTION COULD NOT BE DETECTED AND THEREFORE THE COMPLAINT IS CONSIDERED AS NOT CONFIRMED. BECAUSE COMPLAINT PROCESSING DEPARTMENT RECEIVED NO BATCH INFORMATION FROM THE CUSTOMER, AN EXAMINATION IS NOT POSSIBLE IF THERE WERE ANY ABNORMALITIES IN THE MANUFACTURING PROCESS OR IN THE CHECK ROUTINE OF THE FINAL CONTROL. 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.

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

Description of Event or Problem

ACCORDING TO THE EVENT DESCRIPTION: "DURING THE INSERTION AND REMOVAL OF THE EPIDURAL CATHETER, IT DID NOT RETRACT COMPLETELY; IT WAS MISSING 6 CM. CONSEQUENCE: THE NEUROSURGEON AND SOS ALR (A REGIONAL ANESTHESIA SERVICE) WERE CONTACTED TO DETERMINE THE APPROPRIATE COURSE OF ACTION. NO FURTHER EPIDURAL ANESTHESIA WAS ADMINISTERED. HOWEVER, A CESAREAN SECTION WAS SUBSEQUENTLY REQUIRED, NECESSITATING SPINAL ANESTHESIA, WHICH WAS INEFFECTIVE. ULTIMATELY, GENERAL ANESTHESIA WAS ADMINISTERED."