NIAGARA

Additional Manufacturer Narrative

H11: SECTION A THROUGH F - THE INFORMATION PROVIDED BY BD REPRESENTS ALL OF THE KNOWN INFORMATION AT THIS TIME. DESPITE GOOD FAITH EFFORTS TO OBTAIN ADDITIONAL INFORMATION, THE COMPLAINANT / REPORTER WAS UNABLE OR UNWILLING TO PROVIDE ANY FURTHER PATIENT, PRODUCT, OR PROCEDURAL DETAILS TO BD. EACH EVENT REPORTED TO BD IS EVALUATED AND INVESTIGATED IN ACCORDANCE WITH OUR COMPLAINT INVESTIGATION PROCEDURES. THE INVESTIGATION PROCESS INCLUDES, BUT IS NOT LIMITED TO, EVALUATION OF THE EVENT DETAILS PROVIDED BY THE COMPLAINT FACILITY, A REVIEW OF COMPLAINT HISTORY, MANUFACTURING RECORDS AND RISK DOCUMENT WHERE APPLICABLE, AND AN EVALUATION OF THE SUBJECT DEVICE WHEN AVAILABLE TO IDENTIFY POTENTIAL CONTRIBUTING FACTORS. THE DEVICE HAS NOT BEEN RETURNED TO THE MANUFACTURER FOR EVALUATION.

Description of Event or Problem

IT WAS REPORTED THAT THE PATIENT WAS ADMITTED TO ICU DUE TO SEPSIS. AS THE PATIENT'S CONDITION WAS SERIOUS AND NEEDED HEMODIALYSIS TREATMENT, THE DOCTOR USED THE CATHETER TO PLACE IT INTO THE RIGHT FEMORAL VEIN FOR THE PATIENT AT THE BEDSIDE AT 13:30, AND THE GUIDEWIRE WAS NOT SMOOTH WHEN HE PULLED IT OUT AFTER PLACING THE CATHETER. AFTER REPEATEDLY ADJUSTING THE POSITION AND PULLING IT OUT, HE FOUND THAT THE GUIDEWIRE HAD BEEN FOLDED INSIDE THE BODY, AND THEN HE IMMEDIATELY REPLACED THIS CATHETER AND RELOCATED THE CATHETER TO CARRY OUT THE NEXT STEP OF THE TREATMENT FOR THE PATIENT. THE PATIENT'S CONDITION WILL BE MONITORED CONTINUOUSLY. THERE WERE NO PIECES RETAINED IN THE PATIENT AND NO INTERVENTION REQUIRED. NO FURTHER INFORMATION PROVIDED.