12F X 20CM SILICONE SINGLE LUMEN CATHETER

Description of Event or Problem

DURING THE DISCONNECTION OF THE DIALYSIS, BLOOD WAS COLLECTED FROM CATHETER WITH THE LUER LOCK-COMPATIBLE CARRIED OUT. BUBBLING WAS OBSERVED IN THE BRANCHS AND AIR INTAKE WITH BLOOD BEADING THE FLEXIBLE OUTER WALL OF THE FEMORAL.

Additional Manufacturer Narrative

WE ARE CURRENTLY WAITING FOR THE DEVICE TO BE RETURNED FOR EVALUATION. DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

Additional Manufacturer Narrative

THE 12F SILICONE HEMO-CATH WAS RETURNED FOR EVALUATION. CLARIFICATION OF THE EVENT, INCLUDING THE LOCATION OF THE LEAK, WAS REQUESTED. HOWEVER, CUSTOMER COULD NOT PROVIDE THE REQUESTED INFORMATION. VISUAL INSPECTION REVEALED A LARGE AMOUNT OF DRIED BLOOD WITHIN THE LUMEN. AFTER DECONTAMINATION THE LUMEN WAS CLEARED. FUNCTIONAL TESTING WAS PERFORMED BY CLAMPING THE DISTAL END OF THE LUMEN WITH HEMOSTATS AND FLUSHING THROUGH THE LUMEN. NO LEAKS OR OTHER ISSUES WERE NOTED. NO PROBLEM FOUND WITH RETURNED DEVICE. NO FURTHER INVESTIGATION IS NECESSARY. DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.