3M¿ CUROS¿ DISINFECTING CAP FOR NEEDLELESS CONNECTORS

Additional Manufacturer Narrative

THE DEVICE HAS NOT BEEN RETURNED TO SOLVENTUM FOR ANALYSIS. THE PHYSICIAN INDICATED THE CUROS CAP WAS PLACED INCORRECTLY ON THE CHEST TUBE PORT; THEREFORE, THIS EVENT IS BEING REPORTED DUE TO USE ERROR. THERE ARE NO ADVERSE TRENDS. SOLVENTUM WILL CONTINUE TO MONITOR.

Description of Event or Problem

A CUSTOMER REPORTED AN ADVERSE EVENT VIA A MEDWATCH REPORT INVOLVING THE USE OF A 3M¿ CUROS¿ DISINFECTING CAP FOR NEEDLELESS CONNECTORS PLACED ON A GETINGE OASIS 3600 CHEST TUBE PLEURAL SPECIMEN PORT. A DAY-SHIFT REGISTERED NURSE OBSERVED THE GREEN ALCOHOL CAP ON THE CHEST TUBE SPECIMEN PORT AFTER THE PATIENT EXHIBITED CONTINUOUSLY INCREASING SUBCUTANEOUS AIR TO THE CHEST AND NECK. THE CAP WAS REMOVED, AND THE PATIENT REPORTEDLY STATED THAT BREATHING BECAME SIGNIFICANTLY EASIER FOLLOWING REMOVAL. THE ATTENDING PHYSICIAN ADVISED THAT A GREEN ALCOHOL CAP SHOULD NOT BE PLACED ON THAT SPECIFIC CHEST TUBE PORT, AS THE PORT OPENS DIRECTLY TO THE CIRCUIT AND MAY ALLOW AIR ENTRY IF CAPPED IMPROPERLY. THE PATIENT REPORTEDLY DEVELOPED EXTENSIVE SUBCUTANEOUS EMPHYSEMA AND SUBSEQUENTLY REQUIRED BILATERAL GILL INCISIONS WITH WOUND VACUUM-ASSISTED CLOSURES. AFTER REMOVAL OF THE GREEN ALCOHOL CAP, THE CHEST TUBE REPORTEDLY FUNCTIONED AS INTENDED. THE REPORTING FACILITY BELIEVES THE ALCOHOL CAP MAY HAVE BEEN PLACED AT AN ANGLE, POTENTIALLY PREVENTING PROPER SEALING. THE CHEST TUBE WAS REPLACED DURING THE EVENING HOURS. THE GREEN ALCOHOL CAP WAS DISCOVERED LATE THE FOLLOWING MORNING. IT COULD NOT BE DETERMINED WHETHER THE CAP WAS PLACED DURING THE NIGHT SHIFT OR THE DAY SHIFT.