ARGYLE

Additional Manufacturer Narrative

AN INVESTIGATION IS CURRENTLY UNDERWAY. UPON COMPLETION, THE RESULTS WILL BE FORWARDED.

Description of Event or Problem

THE CUSTOMER REPORTED THAT THE CATHETER NOTED TO BE LEAKING IV FLUIDS AT THE CONNECTION BETWEEN THE CATHETER AND THE BUTTERFLY PLASTIC CLIP PORTION. THERE WAS NO HARM REPORTED.

Additional Manufacturer Narrative

THE DEVICE HISTORY RECORD REVIEW COULD NOT BE PERFORMED SINCE NO LOT NUMBER WAS PROVIDED. THERE WERE NO PHOTOS OR PHYSICAL SAMPLES RECEIVED FOR EVALUATION. BECAUSE A SAMPLE WAS NOT RETURNED, WE WERE UNABLE TO PERFORM A FOLLOW UP INVESTIGATION TO INCLUDE FUNCTIONAL AND VISUAL EVALUATIONS TO CONFIRM THE ISSUE AND ROOT CAUSE ANALYSIS. AT THIS TIME, A CORRECTIVE AND PREVENTIVE ACTION IS NOT DEEMED NECESSARY. WE WILL CONTINUE TO TRACK AND TREND THROUGH OUR MONITORING PROGRAMS AND TAKE ACTIONS AS APPLICABLE.