SECURACATH

Additional Manufacturer Narrative

THIS EVENT WAS BROUGHT TO INTERRAD MEDICAL CLINICAL EDUCATOR'S ATTENTION WHILE PROVIDING TRAINING TO A DIFFERENT DEPARTMENT IN THE HOSPITAL. THE EVENT HAD HAPPENED SOMETIME IN THE PAST, POTENTIALLY ON OR AROUND (B)(6) 2019 THEREFORE IT WAS DIFFICULT TO GET ALL THE DETAILS ABOUT THE EVENT. THE DEVICE WAS NOT RETURNED FOR EVALUATION. MULTIPLE ATTEMPTS HAVE BEEN MADE TO COLLECT MORE DETAILS ABOUT THE EVENT HOWEVER, NO FURTHER DETAILS HAVE BEEN PROVIDED. IF ANY NEW RELEVANT INFORMATION IS PROVIDED IN THE FUTURE, A FOLLOW UP REPORT WILL BE SUBMITTED TO UPDATE THIS REPORT. THE CATHETER DISLODGEMENT HAPPENED WHEN THE PATIENT WAS GOING FROM STANDING TO SITTING AFTER GETTING OUT OF BED WITH MULTIPLE LINES ATTACHED TO THE CATHETER. THE DISLODGEMENT WAS MOST LIKELY DUE TO AN EXCESSIVE TENSILE FORCE BEING APPLIED TO THE LINE DURING PATIENT MOVEMENT. THE SECURACATH DEVICE IS NOT INTENDED TO HOLD WHEN AN EXCESSIVE TENSILE FORCE IS APPLIED (I.E. IF THE LINE WAS CAUGHT ON IV STAND WHEN GOING FROM STANDING TO SITTING). AN EXCESSIVE TENSILE FORCE APPLIED TO THE CATHETER CAN BE MITIGATED WITH PROPER DRESSING TECHNIQUE AND LINE MANAGEMENT. AT THIS TIME THERE IS NOT ENOUGH INFORMATION TO DETERMINE THE CAUSE OF THE DISLODGEMENT BUT BASED ON COMMUNICATIONS (EMAILS AND IN-PERSON) WITH MULTIPLE PEOPLE AT THE HOSPITAL THIS WAS RELATED TO AN ACCIDENTAL EXCESSIVE FORCE BEING APPLIED TO THE CATHETER.

Description of Event or Problem

A PATIENT WITH QUAD-LUMEN CVC "FELL OUT" WHEN SHE WAS BEING ASSISTED FROM BED TO A CHAIR WITH MULTIPLE MEDICATIONS (INCLUDING VASOPRESSORS) RUNNING. WHEN THE PATIENT SAT DOWN IN THE CHAIR SHE COMPLAINED OF FEELING SOMETHING WET. THE NURSE CHECKED AND THE ENTIRE LINE WAS PULLED OUT AND THE SECURACATH WAS STILL IN PLACE. VASOPRESSORS WERE GIVEN PERIPHERALLY UNTIL ANOTHER CVC WAS PLACED TO RESUME PATIENT TREATMENT.