UMBILICAR CATHETER

Additional Manufacturer Narrative

THE INVOLVED SAMPLE FOR INVESTIGATION HAS BEEN DISCARDED. FROM THE DESCRIPTION, THIS UMBILICAL CATHETER WAS INSERTED IN CORRECT POSITION AND WAS FUNCTIONING CORRECTLY FOR 2 DAYS. WE DO NOT KNOW HOW THE CATHETER WAS SECURED , DRESSED, HANDLED , HOW THE REFECTION OF DRESSING WAS DONE ETC. THE BATCH REVIEW SHOWS THAT IT IS COMPLIANT. THERE IS NO DEVIATION. ALL UMBILICAL CATHETERS ARE CONTROLLED , INCLUDING 100% TESTS CARRIED OUT ON EACH CATHETER DURING THE MANUFACTURING PROCESS. THESE TESTS ARE AS FOLLOWS: THE BLUNTNESS OF THE CATHETER TIP , MARKING THE CATHETERS , LENGTH , NON-OBSTRUCTION AND TIGHTNESS. OUR DEVICES ARE COMPLIANT TO NORM ISO 10555-1. EFFUSION IS A WELL-KNOWN COMPLICATION OF UMBILICAL CATHETER. THIS COMPLICATION IS ASSOCIATED WITH THE PLACEMENT OF UMBILICAL CATHETER OR TO THE POOR CONDITION OF EXTREMELY PREMATURE BLOOD VESSELS. THEREFORE, THIS SERIOUS ADVERSE EVENT SEEMS NOT LINKED TO THE QUALITY OF OUR DEVICE. FROM OUR HISTORICAL ANALYSIS OF COMPLAINTS, THESE 3 LAST YEARS ON ALL UMBILICAL CATHETER RANGE CODE 1270.XX, THERE WAS NO OTHER OCCURRENCE OF SIMILAR ADVERSE EVENT DESCRIBING A PERITONEAL EFFUSION. FURTHERMORE, THERE IS NO COMPLAINT AND NO OTHER SERIOUS EVENT OF THE INVOLVED BATCH.

Description of Event or Problem

PRETERM OF 28 WEEKS + 1, 2 DAYS OLD WHEN THE EVENT OCCURED. UMBILICAL CATHETER INSERTED ON 16TH JUNE; POSITION CONTROLLED BY X-RAY AFTER ITS INSERTION. AT SECOND DAY, AN ADDITIONAL POSITION CONTROL BY X-RAY HAS BEEN DONE WITH AN ABDOMINAL ULTRASOUND. A LARGE PERITONEAL EFFUSION WAS NOTICED, POTENTIAL PERFUSO PERITONEUM ON UMBILICAL CATHETER. THE NEONATE WAS INTUBATED AND TAKEN INTO EMERGENCY CARE FOR DRAINAGE.