PERIFIX®

Additional Manufacturer Narrative

THIS REPORT HAS BEEN IDENTIFIED AS B. BRAUN MEDICAL INTERNAL REPORT NUMBER (B)(4). COMPLAINT PROCESSING RECEIVED NO SAMPLE AND NO PICTURE. THE FOLLOWING INVESTIGATIONS WERE CONDUCTED: VISUAL INSPECTION: NO SAMPLE WAS RECEIVED AND THUS A FURTHER EVALUATION AND INVESTIGATION OF THE COMPLAINT IS NOT POSSIBLE. BECAUSE NO BATCH INFORMATION WAS RECEIVED, AN EXAMINATION IS NOT POSSIBLE IF THERE WERE ANY ABNORMALITIES IN THE MANUFACTURING PROCESS OR IN THE CHECK ROUTINE OF THE FINAL CONTROL. AS NO SAMPLE AND NO PICTURE WAS PROVIDED FOR INVESTIGATION A MALFUNCTION COULD NOT BE DETECTED AND THEREFORE THE DEFECT IS CONSIDERED AS NOT CONFIRMED. 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: "DURING AN EPIDURAL INSERTION IN THE L3-L4 SPACE, AN ATTEMPT WAS MADE TO RAISE THE EPIDURAL CATHETER TO 4 CM. THE CATHETER BECAME BLOCKED DURING INSERTION. UPON REMOVAL, THE CATHETER RUPTURED, LEAVING 6 CM OF THE CATHETER IN THE SUBCUTANEOUS SPACE. AN EPIDURAL CATHETER WAS INSERTED IN THE SAME INTERVERTEBRAL SPACE, WITHOUT BLOCKING, 4 CM FROM THE SKIN. RISKS FOR THE PATIENT: INFECTION, NEUROPATHIC PAIN, ETC., RISKS EXPLAINED TO THE PATIENT, MONITORING DURING THE REST OF HER STAY: AFEBRILE, NO NEUROPATHIC PAIN, DISCHARGED HOME. ACTIONS TAKEN AT THE HEALTHCARE FACILITY FOR THE PATIENT'S CARE: INSERTION OF ANOTHER CATHETER, SUBSEQUENT CT SCAN, EXPLANATIONS TO THE PATIENT."