PENCAN®

Additional Manufacturer Narrative

THIS REPORT HAS BEEN IDENTIFIED AS B. BRAUN MEDICAL INTERNAL REPORT NUMBER: (B)(4). ONE PHOTO WAS PROVIDED FOR EVALUATION. VISUAL EVALUATION OF THE PHOTO WAS DIFFICULT DUE TO THE QUALITY. IT APPEARED TO SHOW POSSIBLY TWO NEEDLES, ONE OF WHICH WAS BROKE, OR ONE BROKEN NEEDLE WITH TWO PARTS. THE PROVIDED PICTURE DOES NOT OFFER THE DETAILS NECESSARY TO CONFIRM THE REPORTED DEFECT OR DETERMINE ANY ROOT CAUSE AT THIS TIME. 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 INSTRUCTIONS FOR USE FOR KIT AND COMPONENT WARNINGS AND CAUTIONS. INSTRUCTIONS FOR USE PROVIDED ELECTRONICALLY AT WWW.BBRAUNUSA.COM. 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: THE PATIENT UNDERWENT A SCHEDULED CESAREAN SECTION (C-SECTION) ON (B)(6) 2026. THE PATIENT WAS TAKEN TO THE OPERATING ROOM (OR) AT APPROXIMATELY 07:35 AND POSITIONED FOR SPINAL ANESTHESIA. DURING PLACEMENT OF THE SPINAL ANESTHETIC, THE SPINAL NEEDLE BECAME LODGED IN THE PATIENT'S BACK AND COULD NOT BE REMOVED. THE NEEDLE SUBSEQUENTLY FRACTURED, LEAVING A PORTION RETAINED IN THE PATIENT. THE C-SECTION PROCEDURE WAS COMPLETED. A SURGICAL CONSULTATION WAS OBTAINED FOR REMOVAL OF THE RETAINED NEEDLE FRAGMENT. THE PATIENT WAS SCHEDULED TO RETURN TO THE OR FOR RETRIEVAL OF THE RETAINED DEVICE. THE COMPLAINT DEVICE IS NOT AVAILABLE TO BE RETURNED TO THE MANUFACTURER FOR EVALUATION.