PERIFIX®

Additional Manufacturer Narrative

THIS REPORT HAS BEEN IDENTIFIED AS B. BRAUN MEDICAL INTERNAL REPORT NUMBER (B)(4). NO SAMPLE AND/OR LOT NUMBER WERE PROVIDED. FURTHER INVESTIGATION OF THE COMPLAINT IS NOT POSSIBLE WITHOUT A SAMPLE AND/OR LOT NUMBER. THE REPORTED DEFECT WAS UNABLE TO BE CONFIRMED. THE ACTUAL DEFECTIVE DEVICE IS VALUABLE TOOL IN INVESTIGATING THE CAUSE OF THIS INCIDENT. 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

PER MEDWATCH NUMBER (B)(4): DESCRIBE EVENT OR PROBLEM: THE CATHETER SHEARED WHILE BEING REMOVED FROM THE PATIENT. THE WIRE COIL SEPARATED FROM THE PLASTIC SHEATH. A PORTION OF THE PLASTIC SHEATH APPEARS TO HAVE REMAINED INSIDE THE PATIENT. THE PLASTIC SHEATH WAS UNABLE TO BE LOCATED ON CT OR MRI. THE MANUFACTURER HAS INFORMED US THAT THE PLASTIC SHEATH IS RADIO TRANSLUCENT, WHILE THE WIRE COIL IS RADIOPAQUE. THIS IS LIKELY WHY WE WERE UNABLE TO VISUALIZE THE PLASTIC SHEATH WITH IMAGING (THE WIRE COIL SEPARATED FROM THE PLASTIC SHEATH, SO THE WIRE COIL WAS FULLY REMOVED FROM THE PATIENT). THE PRODUCT SAFETY CONCERN IN THIS CASE IS THAT THE PLASTIC SHEATH IS NOT RADIOPAQUE. MAKING THE PLASTIC SHEATH RADIOPAQUE WOULD ALLOW FOR IT TO BE LOCATED IN SITUATIONS SUCH AS THESE.

Additional Manufacturer Narrative

THIS REPORT HAS BEEN IDENTIFIED AS B. BRAUN MEDICAL INTERNAL REPORT NUMBER (B)(4). ONE USED CATHETER WITHOUT PACKAGING WAS PROVIDED FOR EVALUATION. UPON VISUAL INSPECTION OF THE RETURNED SAMPLE, IT WAS OBSERVED TO BE SHEARED, DAMAGED, AND THE COIL WAS PULLED/ STRETCHED OUT OF THE CATHETER. BASED ON THE DATA FROM THE INVESTIGATION, THE REPORTED DEFECT WAS UNABLE TO BE CONFIRMED TO BE A MANUFACTURING DEFECT. PER THE MANUFACTURERS INVESTIGATION THIS DEFECT IS NOT LIKELY TO HAVE HAPPENED DURING THE MANUFACTURING PROCESS. IT IS BELIEVED TO HAPPEN DURING APPLICATION. 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.