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 NOT CAUSED BY A CATHETER DEFECT BUT TRACED TO ITS IMPROPER PROCEDURE. THEREFORE, NO CORRECTIVE ACTION HAS BEEN INITIATED AT THIS TIME.

Description of Event or Problem

THE SERIOUS ADVERSE EVENT OCCURRED ON A NEWBORN OF 37 WEEKS, WEIGHT 3080 G. FRACTURE OF INTRAVASCULAR UMBILICAL CATHETER. APPROXIMATELY 2CM FRAGMENT OF CATHETER LODGED IN RIGHT ATRIUM. THE PATIENT IS CURRENTLY IN GOOD CONDITION THE PATIENT WAS TRANSFERRED IS THIS HOSPITAL ON (B)(6) 2025. ARTERIAL AND VENOUS UMBILICAL CATHETER WERE INSERTED, SECURING THE VENOUS CATHETER AT 11CM AND THE ARTERIAL CATHETER AT 18CM. BOTH POSITIONS WERE CONFIRMED BY X-RAY. NO DEFECTS WERE NOTICED DURING PRIMING AND CATHETER'S INSERTION. NORMAL RADIOLOGICAL PLATE. HOWEVER, THE 24TH HOURS X-RAY CONTROL PLATE SHOWS A FOREIGN BODY. A LATERAL X-RAY PLATE IS TAKEN, AND IT IS NOTICED THAT IT IS APPROXIMATELY 2 CM FRAGMENT OF THE UMBILICAL CATHETER. IT WAS REMOVED BY AN ADDITIONAL INVASIVE PROCEDURE.