ARGYLE

Additional Manufacturer Narrative

THE DEVICE HISTORY RECORD (DHR) REVIEW COULD NOT BE PERFORMED SINCE NO LOT NUMBER WAS PROVIDED. THE PHYSICAL DEVICE WAS RECEIVED FOR EVALUATION, AND THE REPORTED CONDITION WAS NOT OBSERVED, A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED. BASED ON THIS INFORMATION, NO FURTHER ACTIONS ARE WARRANTED AT THIS TIME. WE WILL CONTINUE TO TRACK AND TREND THROUGH OUR MONITORING PROGRAMS AND TAKE ACTIONS AS APPLICABLE.

Description of Event or Problem

THE CUSTOMER REPORTED THAT THE PATIENT HAD TWO CENTRAL LINES INSERTED, UMBILICAL VENOUS LINE AND UMBILICAL ARTERIAL LINE. THE UMBILICAL VENOUS LINE NOTED TO BE LEAKING IV FLUID AND THE MD ASSESSED AND DECISION WAS MADE TO REMOVE BOTH UMBILICAL LINES. THERE WAS NO BLEEDING NOTED. THE PATIENT TOLERATED WELL AND FAMILY MADE AWARE.

Additional Manufacturer Narrative

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