UMBILICAL CATHETER

Description of Event or Problem

AT 0730HR A NURSE FOUND UVC SECONDARY LUMEN END FOUND DISCONNECTED. DISCONNECTION WAS FROM GREEN UVC CATHETER HUB TO EXTENSION TUBING. INFUSION WAS PREVIOUSLY LOCKED FROM PUMP AFTER A MEDICATION LAST ADMINISTERED AT APPROXIMATELY 0500HRS. ON INSPECTION, SECONDARY UVC LINE WAS UNCLAMPED WITH HUB OPEN TO AIR, CLEAR FLUID IN BOTTOM OF HUB. NO BLOOD LOSS NOTED ON SHEETS OF BED, NO WET FLUID NOTED ON SHEETS. IMMEDIATE INTERVENTION BY WRITER WAS CLAMPING THE LINE CLOSED, SCRUBBED WITH CHLOROPREP AND END CAPPED WITH BLUE NEUTRON. NO FLUSH GIVEN. ATTENDING NEONATOLOGIST AT BEDSIDE AND NOTIFIED. ALL OTHER CONNECTIONS CHECKED AND TRACED.

Additional Manufacturer Narrative

THE MALFUNCTIONING DEVICE WILL BE RETURNED FOR EVALUATION AS PART OF THE COMPLAINT INVESTIGATION. UPON RECEIPT, IT WILL BE INVESTIGATED. THE RESULTS OF THE INVESTIGATION ARE STILL PENDING AND WILL BE COMMUNICATED TO FDA WITHIN THIRTY DAYS OF ITS CONCLUSION VIA A FOLLOW-UP MDR.