UMBILICAL CATHETER

Additional Manufacturer Narrative

WE RECEIVED THE DEFECTIVE SAMPLE FOR INVESTIGATION ALONG WITH 15 UNUSED SAMPLES. ANALYSIS OF THE SAMPLE IN QUESTION SHOWS THAT IT HAS A VERTICAL CUT AT THE 8 CM MARK. WE ALSO NOTICED A SCRATCH ON THE TUBE BEFORE AND AFTER THE CUT. THE CUT IN THE TUBE CAUSED A LEAK. ANALYSIS OF THE 15 UNUSED SAMPLES SHOWED NO ANOMALIES (NO SCRATCHES, NO CUTS, NO LEAKS); THEY WERE ALL COMPLIANT. WE RECOMMEND THAT THE CATHETER SHOULD BE PRIMED. IT IS INDICATED THAT THE LEAK OCCURRED AFTER 1 DAY OF USE. THIS MEANS THAT IT WAS FUNCTIONAL FOR 1 DAY WITHOUT ANY PROBLEMS. IN THE IFU IT IS STATED: "DO NOT CRIMP OR BEND THE CATHETER FOR OCCLUDING IT, EVEN TEMPORARILY. DO NOT ADD CLAMP ON SINGLE-LUMEN CATHETERS. THIS ADDITIONAL STRESS ON THE CATHETER CAN LEAD TO LEAKS OR CRACKS. DO NOT APPLY SHARP OR ROUGH-EDGED INSTRUMENTS DIRECTLY TO THE CATHETER: EVEN A MINOR CUT COULD TEAR IT OR BREAK IT. DO NOT DELIBERATELY CUT THE CATHETER." OUR CATHETERS ARE 100% LEAK TESTED DURING MANUFACTURE. AFTER CHECKING THE BATCH HISTORY RECORDS, NO DEVIATION WAS FOUND. THE BATCH WAS WITHIN SPECIFICATION AND WAS RELEASED. WE HAVE NOT RECORDED A SIMILAR COMPLAINT FOR THIS BATCH, OR ON THIS CODE IN THE LAST 3 YEARS. THE CAUSE OF THE DEFECT IS NOT ATTRIBUTABLE TO OUR DEVICE BUT TO THE CONDITIONS OF USE. CORRECTIVE ACTION: BASED ON THE INVESTIGATION, THE CAUSE OF THE DEFECT IS NOT ATTRIBUTABLE TO THE DEVICE BUT TO THE CONDITIONS OF USE. THEREFORE, NO FURTHER CORRECTIVE ACTION WILL BE INITIATED AT THIS TIME.

Description of Event or Problem

J WRIGHT, NNP PLACED UVC ON PATIENT UPON ADMISSION TO NICU. OVERNIGHT, (B)(6), RN NOTED CONTINUOUS LEAKING AROUND SITE (INITIALLY BELIEVED TO BE OOZING OF SEROSANGUINOUS FLUID) UNTIL 7 AM AT SHIFT CHANGE, THERE WAS POOLING OF CLEAR FLUID NOTED AFTER D10 BOLUS ADMINISTERED, PT CHEMS WERE NOT IMPROVED AFTER MULTIPLE BOLUSES. LINE BELIEVED TO BE LEAKING NNP CONTACTED AND CAME TO BEDSIDE. LINE PULLED AND NEW UVC PLACED. SKIN BREAKDOWN FROM OOZING/LEAKING OVERNIGHT NOTED AND DOCUMENTED WITH PHOTO IN PT CHART.

Description of Event or Problem

(B)(6) , NNP PLACED UVC ON PATIENT UPON ADMISSION TO NICU. OVERNIGHT, (B)(6) , RN NOTED CONTINUOUS LEAKING AROUND SITE (INITIALLY BELIEVED TO BE OOZING OF SEROSANGUINOUS FLUID) UNTIL 7 AM AT SHIFT CHANGE, THERE WAS POOLING OF CLEAR FLUID NOTED AFTER D10 BOLUS ADMINISTERED, PT CHEMS WERE NOT IMPROVED AFTER MULTIPLE BOLUSES. LINE BELIEVED TO BE LEAKING NNP CONTACTED AND CAME TO BEDSIDE. LINE PULLED AND NEW UVC PLACED. SKIN BREAKDOWN FROM OOZING/LEAKING OVERNIGHT NOTED AND DOCUMENTED WITH PHOTO IN PT CHART. .

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.