COOK DOUBLE LUMEN VENOUS CATHETER

Description of Event or Problem

ON 8/14/92, THE PATIENT PRESENTED TO THE CLINIC STATING THAT HER CATHETER WAS LEAKING AT THE INSERTION SITE. THE CATHETER WAS REMOVED AND NOTED TO BE FRACTURED AT 7CM LENGTH. CHEST X-RAY REVEALED THE REMAINING CATHETER SEGMENT IN THE INFERIOR VENA CAVA. BY THE TIME THE PATIENT WAS TRANSPORTEDD TO RADIOLOGY FOR RETRIEVAL OF THE CATHETER, IT HAD MIGRATED TO THE SUPERIOR VENA CAVA AND RT ATRIUM. IT WAS SUCCESSFULLY RETREIVEDINVALID 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: NONE OR UNKNOWN. CONCLUSION: NONE OR UNKNOWN. CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT: MAYBE. CORRECTIVE ACTIONS: DEVICE DISCARDED. THE DEVICE WAS DESTROYED/DISPOSED OF.