PENCAN®

Additional Manufacturer Narrative

THIS REPORT HAS BEEN IDENTIFIED AS B. BRAUN INTERNAL REPORT NUMBER (B)(4). PLEASE NOTE, THIS DEVICE IS DISTRIBUTED OUTSIDE THE US AND NO GUDID INFORMATION EXISTS. IT IS BEING REPORTED DUE TO A SIMILAR DEVICE BEING MARKETED WITHIN THE US WITH THE FOLLOWING INFO: UDI NUMBER: (B)(4). PREMARKET SUBMISSION # K112515 COMPLAINT PROCESSING DEPARTMENT RECEIVED ONE USED PENCAN BULK NL 0.53 X 103 OUT OF A PENCAN 25GX103MM NRFIT M. L. INT.-EU IN OPEN PACKAGING. THE FOLLOWING INVESTIGATION WERE CONDUCTED: VISUAL INSPECTION: THE RECEIVED USED SAMPLE WAS TAKEN TO A VISUAL INSPECTION FOR DAMAGES ACCORDING TO THE TEST PLAN AND TEST METHOD 102002_DAMAGES. THE USED PENCAN CANNULA IS BROKEN OFF AND BENT APPROX. 51 MM AWAY FROM THE CANNULA HUB. THE BROKEN OFF PART OF THE CANNULA WAS NOT HANDED OVER BY THE CUSTOMER. THE AREA OF THE BREAK FROM THE RAW CANNULA SHOWS THAT THE CANNULA WAS BENT BEFORE THE BREAK. BATCH REVIEW: AFTER CHECKING THE RESPECTIVE DOCUMENTATION OF THE PRODUCTION, SHIFT RECORD, RESULTS OF WORKER SELF-INSPECTION AND IN-PROCESS CONTROL, MACHINE DOCUMENTATION, CLEANING RECORD ETC., NO DEVIATIONS COULD BE IDENTIFIED IN THE MENTIONED TIME PERIOD. SUMMARY AND ASSESSMENT: BECAUSE THE SAMPLE WAS ALREADY USED AND BEND, IT WAS ASSUMED A PROBLEM DURING THE APPLICATION PROCESS OCCURRED. BUT RELATING TO THE DAMAGED/ BROKEN OFF CANNULA, THE TESTED SAMPLE IS NOT WITHIN THE SPECIFICATION. THE DEFECT IS CONSIDERED AS CONFIRMED.

Description of Event or Problem

ACCORDING TO THE EVENT DESCRPTION: SPINAL ANESTHESIA PERFORMED UNDER NORMAL CONDITIONS. BONE CONTACT OCCURRED TWICE, REQUIRING THE NEEDLE TO BE WITHDRAWN FOR A NEW PUNCTURE. NEEDLE BREAKAGE WAS OBSERVED, WITH THE ANTERIOR END REMAINING IN PLACE. X-RAY TAKEN WITH ANOTHER NEEDLE IN THE INFERIOR SPACE. ATTEMPT TO WITHDRAW THE NEEDLE WITH FORCEPS USING IMAGE INTENSIFIER SHOWED THE NEEDLE'S POSITION, IN CONTACT WITH THE SPINOUS PROCESS. FAILURE. REMOVAL BY SPINAL SURGEON UNDER GENERAL ANESTHESIA.