PENCAN®

Additional Manufacturer Narrative

THIS REPORT HAS BEEN IDENTIFIED AS B. BRAUN MEDICAL INTERNAL REPORT NUMBER (B)(4). ONE (1) SAMPLE AND TWO (2) PHOTOS WERE SUBMITTED TO THE MANUFACTURER FOR EVALUATION. THROUGH VISUAL EXAMINATION OF THE PHOTOS, NEEDLE BREAKAGE WAS OBSERVED. THROUGH VISUAL EXAMINATION OF THE RETURNED SAMPLE, A BROKEN NEEDLE WAS IDENTIFIED, AND THE OTHER HALF OF THE NEEDLE APPEARED BENT. RETAINED SAMPLES WERE VISUALLY INSPECTED AND NO ABNORMALITIES WERE FOUND. STIFFNESS TEST PERFORMED, TO VERIFY THE STRENGTH OF THE CANNULA PIPE AND IT WAS CONFIRMED TO MET SPECIFICATION STANDARDS. 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. BASED ON THE INVESTIGATION OF THE PHOTOS AND THE RETURNED SAMPLE, THE SHAPE OF THE FRACTURED AREA WAS DETERMINED TO RESEMBLE THE SHAPE OBSERVED WHEN A CANNULA IS REPEATEDLY BENT UNTIL IT BREAKS. BASED ON THESE FINDINGS, IT IS PRESUMED THAT THE CAUSE OF THE CANNULA FRACTURE WAS DUE TO REPEATED BENDING DURING HANDLING. THE REPORTED DEFECT IS NOT CONFIRMED TO BE FROM A MANUFACTURING PROCESS ISSUE. 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: BRIEF INQUIRY DESCRIPTION: BROKEN SPINAL NEEDLE. DETAILED INQUIRY DESCRIPTION: WE HAD A 22G 3 3.5 IN SPINAL NEEDLE REF# (B)(4), BREAK OFF INSIDE OF THE PATIENT RESULTING IN THE CANCELLATION OF THE SURGICAL CASE AND A NEED TO HAVE GENERAL SURGERY RETRIEVE THE BROKEN PORTION THAT REMAINED ON THE PATIENT.

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.