MCGAW

Description of Event or Problem

THE PATIENT CALLED TO SAY THAT HE NOTICED FLUID LEAKING FROM THE END OF HIS GROSHONG CATHETER. HE TWISTED THE CAP TO SEE IF IT WAS SECURE AND THE TOP OF THE CAP BROKE OFF. THE LUER LOCK PORTION OF BROKEN CAP REMAINED IN THE GROSHONG AND COULD NOT BE REMOVED. THE PATIENT HAD TO GO TO A HOSPITAL ER TO REPLACE THE END OF HIS GROSHONG CATHETER.INVALID DATA - REGARDING SINGLE USE LABELING OF DEVICE. PATIENT MEDICAL STATUS PRIOR TO EVENT: SATISFACTORY CONDITION. 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, VISUAL EXAMINATION. RESULTS OF EVALUATION: OTHER. CONCLUSION: NONE OR UNKNOWN. CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT: MAYBE. CORRECTIVE ACTIONS: OTHER. INVALID DATA - ON DEVICE DESTROYED/DISPOSED OF STATUS.