DUAL LUMEN 3.5FR POLYURETHANE UMBILICAL CATHETER

Additional Manufacturer Narrative

INVESTIGATION OF THE RETURNED DEVICE DID NOT IDENTIFY ANY MANUFACTURING OR DESIGN RELATED REASON THAT WOULD HAVE CONTRIBUTED TO FLUID INFILTRATION. INTERVIEW WITH THE FACILITY CLINICAL STAFF INDICATED THAT CATHETER PLACEMENT WAS PROPER BEFORE AND AFTER THE EVENT, AND THAT THE MODE OF INFILTRATION MAY HAVE BEEN RELATED TO THE VESSEL BECOMING PERMEABLE OR DISSECTION BY THE UVC, ALTHOUGH NO DISSECTION WAS ABLE TO BE VERIFIED RADIOGRAPHICALLY. THE RETURNED DEVICE EXHIBITIED AN ATRAUMATIC TIP AND THE BODY OF THE CATHETER WAS SMOOTH AND UNEXCEPTIONAL.

Description of Event or Problem

TWO DAYS FOLLOWING THE PLACEMENT OF AN UMBILICAL VESSEL LINE IN A MICROPREEMIE, IT WAS NOTED THAT THE PATIENT PRESENTED WITH WORSENING RESPIRATORY STATUS. THREE DAYS FOLLOWING PLACEMENT OF THE UVC, THE PATIENT PRESENTED WITH METABOLIC ACIDOSIS, WORSENING PLEURAL EFFUSION, AND FLUIDS IN THE SCROTUM. FIVE DAYS FOLLOWING THE PLACEMENT OF THE UVC, THE UVC WAS REMOVED FROM THE PATIENT. TOTAL PARENTERAL NUTRITION (TPN) AND INTRALIPIDS (IL) WERE REPORTED TO HAVE BEEN FLOWING THROUGH THE UVC LINE AT THE TIME OF THE EVENT, AND A SAMPLE OF THE INFILTRATED FLUIDS CONFIRMED THE PRESENCE OF TPN AND IL. UVC WAS VERIFIED TO BE IN PROPER PLACEMENT AT THE TIME OF INSERTION AND AT THE TIME OF THE EVENT. INFANT HAD A SIGNIFICANT CLINICAL CHANGE AFTER THE EVENT, GOING FROM NO IVH TO BILATERAL GRADE IV IVH, AS DETERMINED BY ULTRASOUND.