UMBILICAL CATHETER

Additional Manufacturer Narrative

THE FAILED SAMPLE WILL BE RETURNED TO VYGON FOR DEVICE EVALUATION AS PART OF THE COMPLAINT INVESTIGATION. THE RESULTS OF THIS INVESTIGATION ARE STILL PENDING, AND WILL BE COMMUNICATED TO FDA WITHIN 30 DAYS OF ITS CONCLUSION. THE BATCH REVIEW DOES NOT SHOWN ANY NON-CONFORMITY. THE PRODUCTS ARE IN CONFORMITY WITH THE SPECIFICATIONS. THE DEVICE IS COMPLIANT TO NORM ISO (B)(4). THE TIGHTNESS AND THE ROUNDED TIP OF EACH UMBILICAL CATHETER ARE CONTROLLED. THERE ARE NO OTHER COMPLAINTS WITH THIS BATCH.

Description of Event or Problem

THE CATHETER IS INSERTED IN A NEONATAL PATIENT. A FEW DAYS LATER THE POSITION OF THE CATHETER IS MONITORED BY MEANS OF AN X-RAY AND IT IS OBSERVED EXTRAVASATION OF LIQUIDS ASSOCIATED WITH THE CATHETER, WHICH IS VERIFIED BY ADMINISTERING SALINE SERUM. THE UMBILICAL CATHETER IS COMPLETELY REMOVED FROM THE PATIENT. NO FURTHER INFORMATION RELATED TO THE PLACEMENT CONTROL, THE USE DURATION AND TO THE NEONATAL PATIENT ARE AVAILABLE.

Description of Event or Problem

THE CATHETER IS INSERTED IN A NEONATAL PATIENT. A FEW DAYS LATER THE POSITION OF THE CATHETER IS MONITORED BY MEANS OF AN X-RAY AND IS OBSERVED EXTRAVASATION OF LIQUIDS ASSOCIATED WITH THE CATHETER, WHICH IS VERIFIED BY ADMINISTERING SALINE SERUM. THE UMBILICAL CATHETER IS COMPLETELY REMOVED FROM THE PATIENT. NO FURTHER INFORMATION RELATED TO THE PLACEMENT CONTROL, THE USE DURATION AND TO THE NEONATAL PATIENT ARE AVAILABLE.

Additional Manufacturer Narrative

WE HAVE RECEIVED THE DISTAL PART OF THE INVOLVED UMBILICAL CATHETER. ON VISUAL EXAMINATION, WE CAN NOTICED THAT THE CATHETER TUBE IS BROKEN JUST AFTER THE 6 CM MARKING WITH A LITTLE TUBE SWELLING AND A PINCH MARK BY A FORCEPS AT THIS END. AN UNEVEN ASPECT OF THE FRACTURED SURFACE WAS IDENTIFIED. THE MOST LIKELY CAUSE COULD BE AN OVERPRESSURE CREATED IN THE TUBE OR A DAMAGE OF THE TUBE DURING ITS INSERTION . THESE MAY CRACKED THE TUBE CAUSING THE LEAKAGE AND THEN THE RUPTURE DURING ITS REMOVAL. THE TIGHTNESS OF THIS PART OF TUBE HAS BEEN TESTED AND NO LEAKAGE COULD BE NOTICED. AS THE LEAKAGE OCCURED AFTER 4 DAYS, THE CATHETER SEEMS TO HAVE FUNCTIONING CORRECTLY DURING THIS PERIOD. FURTHERMORE, A 100% TIGHTNESS TEST IS PERFORMED DURING THE MANUFACTURING PROCESS AS THE CATHETER IS PRIMED BEFORE INSERTION, A LEAKAGE DUE TO A FAULTY DEVICE WOULD HAVE BEEN DETECTED AND NOT PLACED. THEREFORE, THE MOST LIKELY ROOT CAUSE IS TRACED TO ITS INSERTION OR USE. THE BATCH REVIEW DOES NOT SHOWN ANY NON-CONFORMITY. THE PRODUCTS ARE IN CONFORMITY WITH THE SPECIFICATIONS. THE DEVICE IS COMPLIANT TO NORM ISO 10555-1. THE TIGHTNESS AND THE ROUNDED TIP OF EACH UMBILICAL CATHETER ARE CONTROLLED . THERE IS NO OTHER COMPLAINT ON THIS BATCH . NO FURTHER CORRECTIVE ACTION INITIATED BY QUALITY MANAGEMENT AS THE CATHETER WORKED WELL FOR 4 DAYS AND THERE ARE NO INDICATIONS OF A MANUFACTURING FAULT.