UMBILICAL CATHETER

Additional Manufacturer Narrative

WE RECEIVED FOR THE INVOLVED SAMPLE FOR INVESTIGATION. THE VISUAL EXAMINATION SHOWS THAT A CUT CAN BE NOTICED BETWEEN THE GRADUATIONS 9 AND 10. BOTH EXTREMITIES ARE SHARP AND BEVELED, WHICH IS CHARACTERISTIC OF A CUT OCCURED BY A SCALPEL BLADE OR A SHARP OBJECT DURING ITS USE. SEE ENCLOSED PICTURE. THE MOST LIKELY ROOT CAUSE OF THIS INCIDENT IS NOT LINKED TO A CATHETER DEFECT BUT TO ITS CONDITIONS OF USE. WE HAVE CHECKED THE HISTORY OF COMPLAINTS, NO FURTHER COMPLAINTS ARE REGISTERED ON THIS BATCH. THE BATCH REVIEW DOES NOT SHOWN ANY DEVIATION OR NON-CONFORMITY.

Description of Event or Problem

AFTER ASEPSIS AND ANTISEPSIS, FUNCTIONAL TESTS ARE PERFORMED IRRIGATING SALINE SOLUTION, THE UMBILICAL ARTERY IS LOCATED, A CATHETER IS PASSED WITHOUT COMPLICATIONS UNTIL IT REACHES 11CM. THE UMBILICAL VEIN IS LOCATED AND A 6CM CATHETER IS PLACED, SUDDENLY, ACCORDING TO THE INSTITUTIONAL PROTOCOL. BLEEDING IS OBSERVED AT THE ARTERIAL CATHETER INSERTION SITE AND THE TOTAL CATHETER RUPTURE IS CORROBORATED CLINICALLY. IT PROCEEDS TO INSPECT, TRYING TO RECOVER LINE, WITHOUT SUCCESS. ABDOMINAL RADIOGRAPHY IS REQUESTED, SHOWING AORTIC CATHETER AND PART OF THE INTRACARDIAC TRACT. INTERCONSULTATION IS REQUESTED WITH THE PEDIATRIC SURGERY AND CARDIOVASCULAR SURGERY SERVICE. THE PATIENT IS STABLE, IN SUITABLE GENERAL CONDITIONS, WITHOUT APPARENT DETERIORATION, WITH VITAL SIGNS TA: 57/35, FC: 139, FR: 56.5%, O2: 98.