DESIGN OPTIONS®

Description of Event or Problem

AS REPORTED BY THE USER FACILITY: BRIEF INQUIRY DESCRIPTION: BROKEN/SNAPPED FX CATHETER. DETAILED INQUIRY DESCRIPTION: END USER REPORTING A BROKEN FX CATHETER USED ON ONE OF THEIR OR PATIENTS PLACED FOR POST-OP PAIN MANAGEMENT. PATIENT WAS MOVED TO A LATERAL POSITION AND THAT IS WHEN THE CATHETER SNAPPED WITH THE SPRINGWOUND COIL EXPOSED. PER THE DOCTOR, NOTHING UNUSUAL NOTED ABOUT THE CATHETER AND THERE WAS NO EXCESSIVE FORCE OR PULLING OF CATHETER TO HAVE CAUSED THIS. THEY SUSPECT THERE WAS A MATERIAL DEFECT IN THE CATHETER MATERIAL. THEY WERE ONLY VISUALLY ALERTED BY IT.

Additional Manufacturer Narrative

THIS REPORT HAS BEEN IDENTIFIED AS B. BRAUN MEDICAL INTERNAL REPORT NUMBER (B)(4). ONE USED, PARTIAL CATHETER WITH LIDSTOCK PACKAGING WAS RETURNED FOR EVALUATION. VISUAL EVALUATION OF THE PHOTO CONFIRMED THE CATHETER TO BE SHEARED APPROXIMATELY 30" FROM THE DISTAL TIP OF THE CATHETER, WITH THE COIL EXPOSED. THE REPORTED DEFECT WAS VISUALLY CONFIRMED. ALTHOUGH THE DEFECT WAS CONFIRMED ON THE RETURNED SAMPLE, THE EXACT ROOT CAUSE OF THE SHEARED CATHETER WAS NOT ABLE TO BE DETERMINED AT THIS TIME. ACCORDING TO THE BLUEPRINT DRAWING, THERE HAVE BEEN NO CHANGE TO ANY MATERIAL OF THE CATHETER. 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.