UMBILICAL CATHETER

Additional Manufacturer Narrative

THE INVOLVED UMBILICAL CATHETER IS NOT AVAILABLE FOR INVESTIGATION. THE REVIEW OF THE INVOLVED BATCH DOES NOT SHOW ANY NON-CONFORMITY. THE PRODUCTS ARE IN CONFORMITY WITH THE SPECIFICATIONS. ALL CONTROLS ARE COMPLIANT, INCLUDING THE 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, TIGHTNESS AND NON-OBSTRUCTION. IN ADDITION, 25 UMBILICAL CATHETERS ARE TESTED BY SAMPLING : -TO CHECK THE TENSILE STRENGTH ACCORDING TO ACCORDING TO NF EN ISO 10555-1 SPECIFICATION >10N. ALL RESULTS ARE COMPLIANT. -TO CHECK THE ABSENCE OF LIQUID LEAKAGE (3BAR/30 SECONDS) AND AIR LEAKAGE WERE DONE, ACCORDING TO NF EN ISO 10555-1. ALL RESULTS COMPLIED (NO AIR OR LIQUID LEAKAGE). THE HISTORICAL DATA ANALYSIS OF COMPLAINTS ON THIS BATCH DOES NOT SHOW ANY COMPLAINT. THIS SERIOUS ADVERSE EVENT IS A WELL-KNOWN COMPLICATION NOT CAUSED BY A CATHETER DEFECT BUT TRACED TO ITS IMPROPER REMOVAL PROCEDURE.

Description of Event or Problem

THE SERIOUS ADVERSE EVENT OCCURRED ON A LATE PREMATURE NEWBORN OF 36 WEEKS. ON HIS 5TH DAY OF LIFE, IN THE NEONATE INTENSIVE CARE UNIT, THE CLINICAL CONDITION WAS IMPROVING AND THE HEMODYNAMIC STABLE. IT WAS DECIDED TO REMOVE THE UMBILICAL CATHETER DURING THE REMOVAL PROCEDURE, IT WAS NOTICED THAT THE CATHETER IS INCOMPLETE, BROKEN, WITH APPROXIMATELY 8 CM MISSING. IT WAS CONFIRMED ON THE ABDOMINAL X-RAY. THEREFORE, AN URGENT EVALUATION BY PEDIATRIC HEMODYNAMICS OR INTERVENTIONAL RADIOLOGY WAS REQUESTED. IT WAS DECIDED WITH INFECTIOLOGY, TO INITIATE ANTICOAGULANT MANAGEMENT. THE PATIENT WAS IMMEDIATELY TREATED BY NEONATOLOGIST AND CONSULTATIONS WITH INTERVENTIONAL RADIOLOGIST AND PEDIATRIC CATHETERIZATION SPECIALIST. ADDITIONAL THERAPEUTIC MEASURES WERE REQUIRED, BUT NO FAVORABLE OUTCOME WAS ACHIEVED. UNFORTUNATELY, THE PATIENT DIED.