CLICK LOCK

Description of Event or Problem

THE RUBBER INJECTION PORT BECOME DISLODGED FROM CLICK LOCK CAP DURING ROUTINE FLUSHING. NO BLOOD LOSS. CLICK LOCK WAS CLAMPED IMMEDIATELY. ACCORDINGLY TO CLINICAL ENGINEERING RUBBER STOPPER HAD SEPERATED FROM THE CAP TAKING THE PLASTIC HOLDING BAND WITH IT. AN UNUSED CAP WAS RANDONLY PULLED FROM STOCK. IT PULLED APART FAIRLY EASILY. THIS IS THE SECOND TIME ONE OF THESE CAPS SEPERATED WHILE IN USE ON THE PATIENTINVALID DATA - REGARDING SINGLE USE LABELING OF DEVICE. PATIENT MEDICAL STATUS PRIOR TO EVENT: UNKNOWN. THERE WAS NOT MULTIPLE PATIENT INVOLVEMENT.INVALID DATA - ON DEVICE SERVICE/MAINTENANCE. NO DATA - REGARDING DATE LAST SERVICED. SERVICE PROVIDED BY: INVALID DATA. INVALID DATA - SERVICE RECORDS AVAILABILITY. NO IMMINENT HAZARD TO PUBLIC HEALTH CLAIMED. DEVICE USED AS LABELED/INTENDED.DEVICE WAS EVALUATED AFTER THE EVENT. METHOD OF EVALUATION: ACTUAL DEVICE INVOLVED IN INCIDENT WAS EVALUATED, A DEVICE FROM SAME LOT WAS EVALUATED, MECHANICAL TESTS PERFORMED, VISUAL EXAMINATION. RESULTS OF EVALUATION: COMPONENT FAILURE, DESIGN - INADEQUATE, MANUFACTURING. CONCLUSION: DEVICE FAILURE DIRECTLY CAUSED EVENT. CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT: YES. CORRECTIVE ACTIONS: NO DATA. INVALID DATA - ON DEVICE DESTROYED/DISPOSED OF STATUS.