5F UMBILICAL CATHETER

Additional Manufacturer Narrative

UPON RECEIPT OF THE SAMPLE, AN INVESTIGATION WILL BE COMPLETED. THE RESULTS OF THIS INVESTIGATION WILL BE FORWARDED TO THE FDA VIA A FOLLOW UP MDR.

Description of Event or Problem

UVC INSERTED INTO UMBILICUS - ABLE TO ADVANCE TO A HIGH LINE BY DR WITH GOOD BLOOD RETURN. UPON XRAY TO CHECK FOR PLACEMENT, UVC WAS NOTED TO BE COILED IN LIVER. LINE PULLED BACK & INSERTED TO A LOW LINE. UPON XRAY IT WAS NOTED THAT THE UVC WAS AGAIN COILED. LINE PULLED AS UNABLE TO INSERT TO CORRECT PLACEMENT WITHOUT BEING COILED. A SIMILAR EVENT HAPPENED THE PREVIOUS WEEK WITH THE UVC CATHETER COILING IN LIVER DESPITE GOOD BLOOD RETURN.