PENCAN®

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.

Description of Event or Problem

AS REPORTED BY THE USER FACILITY: COMPLAINT DESCRIPTION: A NEEDLE BROKE IN THE INTERLAMINAR SPACE OF THE SPINE DURING THE PROCEDURE. THE PATIENT UNDERWENT SURGERY BY AN ORTHOPEDIST TO REMOVE THE PORTION REMAINING IN THE SPACE OF THE SPINE.

Additional Manufacturer Narrative

THIS REPORT HAS BEEN IDENTIFIED AS B. BRAUN MEDICAL INTERNAL REPORT NUMBER (B)(4). ONE PHOTOGRAPH WAS PROVIDED FOR EVALUATION. UPON VISUAL INSPECTION OF THE PICTURE, THE NEEDLE HUB WAS OBSERVED TO NOT BE ATTACHED. ADDITIONALLY, THE NEEDLE EXHIBITED A BEND AT THE LOCATION WHERE THE HUB IS INTENDED TO BE POSITIONED. THE PART IS A PURCHASED PART FROM JAPAN. JAPAN PERFORMED INVESTIGATION AND IDENTIFIED THE DAMAGE. HOWEVER, BASED ON FINDINGS OF INVESTIGATION DID NOT DETERMINE IT WAS THE RESULT OF A MANUFACTURING PROCESS. FIVE RETAINS FROM THE REPORTED LOT NUMBER WERE TESTED AND PASSED PER SPECIFICATION. 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. INCORRECT HANDLING BY THE USER/USER ERROR WAS DETERMINED TO BE A PROBABLE ROOT CAUSE. 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.