PERIFIX®

Description of Event or Problem

AS REPORTED BY THE USER FACILITY: THE PATIENT HAD THE EPIDURAL PLACED BY ANESTHESIA. LATER IN THE DAY SHE STARTED TO COMPLAIN OF SEVERE PAIN. WHEN THE ANESTHESIOLOGIST WENT TO EVALUATE HER AND TRACED THE LINE, HE SAW THAT THE TOP YELLOW ROUND PORTION OF THE CATHETER HAD BROKEN OFF AND THE ENTIRE BED WAS WET.

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.

Additional Manufacturer Narrative

THIS REPORT HAS BEEN IDENTIFIED AS B. BRAUN MEDICAL INTERNAL REPORT NUMBER (B)(4). ONE USED MICRON FILTER WITHOUT PACKAGING WAS PROVIDED FOR INVESTIGATION. UPON EVALUATION OF THE UNIT, THE FILTER WAS TESTED FOR LEAKAGE WITH LEAKAGE OBSERVED FROM A CRACK ON THE FEMALE LUER FITTING OF THE FILTER. NO CATHETER WAS RETURNED TO BE EVALUATED FOR THE REPORTED CONCERN OF BROKEN CATHETER. THE REPORTED CONCERN WAS UNABLE TO BE CONFIRMED TO BE RELATED TO ANY MANUFACTURING PROCESS. A REVIEW OF THE DISCREPANCY MANAGEMENT SYSTEM (DSMS) DATABASE WAS PERFORMED FOR THE REPORTED LOT NUMBER AND NO ABNORMALITIES OR NON-CONFORMANCES WERE NOTED DURING THE IN PROCESS OR FINAL PRODUCT INSPECTION. INCIDENTS OF CRACKED/LEAKING COMPONENTS MAY BE CAUSED BY SEVERAL FACTORS, INCLUDING BUT NOT LIMITED TO THE PRODUCT BEING SUBJECTED TO AGGRESSIVE SOLVENTS/DRUGS, EXCESSIVE MECHANICAL STRESSES (OVER-TIGHTENING OR FREQUENT SET MANIPULATION), OR OTHER VARIOUS UNFORESEEN CIRCUMSTANCES DURING THE CLINICAL APPLICATION. WE WILL MAINTAIN THIS REPORT FOR FURTHER REFERENCES AND CONTINUE TO MONITOR OTHER REPORTS FOR SIMILAR OCCURRENCES. IF ANY ADDITIONAL PERTINENT INFORMATION BECOMES AVAILABLE, A FOLLOW UP WILL BE SUBMITTED.