Description of Event or Problem · 1
DOUBLE LUMEN CENTRAL LINE PLACED IN L SUBDIVISION CONTINUED TO LEAK PROFUSELY AT INSERTION SITE. ATTEMPT WAS MADE TO THREAD NEW CATHETER OVER A GUIDE WIRE @ ORIGINAL INSERTION. FOLLOWING SEVERAL ATTEMPTS, A PORTION OF WIRE WAS BROKEN OFF AND REMAINED LODGED IN VESSEL. PLACEMENT VERIFIED BY CXR; PT. RETURNED TO OR FOR SUCCESSFUL REMOVAL OF WIREDEVICE LABELED FOR SINGLE USE. PATIENT MEDICAL STATUS PRIOR TO EVENT: CRITICAL 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: NONE OR UNKNOWN, NONE OR UNKNOWN, UNANTICIPATED, GUIDEWIRE. CONCLUSION: DEVICE FAILURE DIRECTLY CAUSED EVENT. CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT: INVALID DATA. CORRECTIVE ACTIONS: NONE OR UNKNOWN. THE DEVICE WAS NOT DESTROYED/DISPOSED OF.