PERIFIX®

Description of Event or Problem

AS REPORTED BY USER FACILITY: IT WAS REPORTED TO B. BRAUN MEDICAL INC. THAT A PERIFIX EPIDURAL CATHETER (MATERIAL 332097, LOT 0061944517) WAS BEING USED FOR PAIN MANAGEMENT DURING AN UNSPECIFIED PROCEDURE ON (B)(6) 2024. ACCORDING TO THE COMPLAINANT, RESISTANCE WAS ENCOUNTERED DURING THE PLACEMENT OF THE EPIDURAL CATHETER, WHICH PREVENTED FURTHER ADVANCEMENT. THE DECISION WAS MADE TO REMOVE THE CATHETER, BUT IT FELT LODGED. AFTER WITHDRAWING THE WHOLE EPIDURAL NEEDLE, RESISTANCE WAS AGAIN ENCOUNTERED WHILE ATTEMPTING TO EXTRACT THE REMAINDER OF THE CATHETER. THE CATHETER TIP COULD NOT BE VISUALIZED, INDICATING THAT A PORTION HAD BROKEN OFF AND REMAINED IN THE PATIENT'S LUMBAR REGION. UPON INSPECTION, APPROXIMATELY 15 CENTIMETERS (CM) OF THE CATHETER HAD DETACHED AND WAS RETAINED IN THE PATIENT. THE COMPLAINT DEVICE HAS BEEN RETURNED TO THE MANUFACTURER FOR EVALUATION.

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 SAMPLE WAS PROVIDED FOR EVALUATION. UPON VISUAL INSPECTION OF THE RETURNED SAMPLE, THE CATHETER WAS OBSERVED TO BE DAMAGED, SHEARED, AND THE COIL WAS STRETCHED OUT. BASED ON THE DATA FROM THE INVESTIGATION, THE REPORTED DEFECT WAS UNABLE TO BE CONFIRMED TO BE THE RESULT OF ANY MANUFACTURING PROCESS. PER THE MANUFACTURERS INVESTIGATION, THIS DEFECT WAS NOT LIKELY TO HAVE HAPPENED DURING THE MANUFACTURING PROCESS. IT IS BELIEVED TO HAPPEN DURING APPLICATION. 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. 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.