UMBILICAL CATHETER SNGL LUMEN 3.5FR

Additional Manufacturer Narrative

A SAMPLE WAS RECEIVED AT THE PLANT FOR THE INVESTIGATION. THE DEVICE HISTORY RECORD WAS REVIEWED AND INDICATED THAT THE PRODUCT WAS RELEASED ACCOMPLISHING ALL QUALITY STANDARDS. UPON A FUNCTIONAL EVALUATION OF THE SAMPLE, THE REPORTED ISSUE WAS NOT CONFIRMED; THE CATHETER DID NOT LEAK. A ROOT CAUSE COULD NOT BE DETERMINED. A CORRECTIVE ACTION IS NOT APPLICABLE AT THIS TIME.

Description of Event or Problem

THE CUSTOMER REPORTED THAT THE ITEM FAILED DUE TO A LEAK. THEY USED 2 OF THE SAME LOT AND BOTH FAILED. THEY PROCEEDED TO USE A DIFFERENT LOT AND IT WORKED. THE NURSE REPORTED THAT LINES WERE PLACED AND WITHIN 30 MINUTES OF LINES BEING IN, THEY CLOTTED OFF AND FILLED WITH AIR. PER ADDITIONAL INFORMATION RECEIVED, THERE WAS AIR IN THE LINE. THE DEVICE WAS REPLACED AND NO ISSUE FURTHER ISSUES OCCURRED.

Additional Manufacturer Narrative

AN INVESTIGATION IS CURRENTLY UNDERWAY. UPON COMPLETION, THE RESULTS WILL BE FORWARDED.