PERIFIX®

Additional Manufacturer Narrative

THIS REPORT HAS BEEN IDENTIFIED AS B. BRAUN MEDICAL INTERNAL REPORT NUMBER (B)(4). TWO CATHETER SAMPLES, WITHOUT PACKAGING WERE RETURNED FOR EVALUATION. VISUAL EVALUATION OF THE CATHETERS SHOWED ONE THAT DID NOT APPEAR DAMAGED, WITH THE TIP INTACT AND THE OTHER WAS CONTAMINATED, USED AND SHEARED WITH THE COIL FRAYED AND EXPOSED. ALTHOUGH ONE OF TWO CATHETERS WAS SHEARED, SINCE IT HAD NOT BEEN DAMAGED BEFORE USE, THIS IS NOT CONFIRMED TO BE THE RESULT OF ANY MANUFACTURING PROCESS. B BRAUN KITS ARE PACKAGED ACCORDING TO BLUEPRINT SPECIFICATIONS WHILE INSPECTING FOR ANY DEFECTS OR DEVIATIONS FROM DRAWING (E.G. EMBEDDED PARTICLES, DIRT, MISSING OR INCORRECTLY ASSEMBLED PARTS, ETC.). IN ADDITION, THERE ARE INCOMING, IN PROCESS AND FINAL FUNCTIONAL INSPECTIONS PERFORMED DURING THE MANUFACTURING OF COMPONENTS AND FINISHED GOOD ITEMS. PER THE MANUFACTURERS INVESTIGATION THIS DEFECT IS NOT LIKELY TO HAVE HAPPENED DURING THE MANUFACTURING PROCESS. IT IS BELIEVED TO HAPPEN DURING APPLICATION. USER WILL BE REFERRED TO THE IFU WHICH STATES, PRECAUTION: ADVANCING THE CATHETER MORE THAN 5 CM PAST THE NEEDLE TIP MAY INCREASE THE LIKELIHOOD OF KINKING OR KNOTTING. CONSULT STANDARD TEXTBOOKS FOR SPECIFIC TECHNIQUES." CAUTION: FOR KIT CONTAINING CATHETERS, DO NOT WITHDRAW CATHETER THROUGH NEEDLE DUE TO POSSIBLE DANGER OF SHEARING OR KINKING. 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.

Description of Event or Problem

AS REPORTED BY THE USER FACILITY: CUSTOMER FACILITY RISK MANAGER REPORTED DURING A LIVE THAT THE CATHETER FROM THE CE17TKFS EPIDURAL TRAY BROKE OFF DURING REMOVAL. PORTION OF THE CATHETER (A COUPLE OF INCHES REMAINED IN THE PATIENT). AS SUCH EXPLORATORY SURGERY WAS PERFORMED TO REMOVE THE FRAGMENT. THIS INITIAL SURGERY WAS UNSUCCESSFUL. ADDITIONAL IMAGES WERE REQUIRED, AND ANOTHER EXPLORATORY SURGERY WAS PERFORMED DURING WHICH THE DEVICE WAS REMOVED. PATIENT CURRENT CONDITION: PATIENT DOING FINE NO ISSUES DISCHARGED. THE DEVICE SHEARED - IN THE SPINAL COLUMN THE SPRING PIECE RETAINED IN SITU. MW5170365 RECEIVED ON 28MAY2025 PATIENT WAS HAVING A KNEE REPLACEMENT SURGERY WITH EPIDURAL ANESTHESIA. AT THE END OF THE PROCEDURE WHILE THE EPIDURAL WAS BEING REMOVED, THE END OF THE CATHETER BROKE OFF AND WAS RETAINED WITHIN THE PATIENT. THEY WERE UNABLE TO MANUALLY RETRIEVE THE RETAINED PIECE OF CATHETER. IMAGING WAS DONE TO LOCATE THE PIECE WITHIN THE PATIENT. AFTER IT WAS IDENTIFIED TO BE IN THE PATIENT, SURGERY WAS PERFORMED AND THE RETAINED PIECE WAS SUCCESSFULLY REMOVED FROM THE PATIENT INTERSPINOUS SPACE. THE PATIENT HAD SOME PAIN PRIOR TO REMOVAL BUT NO OTHER DEFICITS RELATED TO THE RETAINED PIECE.