UMBILICAL CATHETER DUAL LUMEN 3.5FR

Additional Manufacturer Narrative

A DECONTAMINATED 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 VISUAL EVALUATION OF THE SAMPLE, THE DEFECT WAS NOT CONFIRMED; THE CATHETER DID NOT PRESENT ANY LEAKS. THEREFORE, A ROOT CAUSE WAS UNABLE TO BE DETERMINED AND A CORRECTIVE ACTION IS NOT APPLICABLE AT THIS TIME.

Additional Manufacturer Narrative

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

Description of Event or Problem

THE CUSTOMER REPORTED THAT THE DOUBLE LUMEN UVC WAS INSERTED PER PROTOCOL. WHILE SECURING DEVICE WITH TAPES (PER PROTOCOL), THE INSERTER NOTED CLEAR FLUID POOLING/LEAKING AROUND THE UMBILICUS. THE FLUID CONTINUED TO RE-ACCUMULATE DESPITE DABBING WITH STERILE GAUZE. THE LINE WAS REMOVED AND REPLACED WITH A NEW LINE. UPON VISUAL INSPECTION, THERE WAS A VERY SMALL LONGITUDINAL DEFECT/HOLE NOTED AROUND THE 4-5 CM MARK.