Description of Event or Problem · 1
MARCH 2, 1992: A RIGHT SUBCLAVIAN LIFE PORT CATHETER WAS PLACED IN SHORT STAY SURGERY AT APPROXIMATELY 7:35 A.M. X-RAY CONFIRMED GOOD POSITION POST PROCEDURE. A FLUOROSCOPIC EXAM WAS DONE DURING THE PROCEDURE.MARCH 12, 1992: DAY 8 OF CHEMOTHERAPY TREATMENT IN PHYSICIAN'S OFFICE. NOTICED A LEAKING AROUND THE PUNCTURE SITE. CHEMOTHERPY WAS STOPPED. PATIENT WAS SCHEDULED FOR DYE EVALUATION IN AN X-RAY UNIT. X-RAY INDICATED THAT THE CATHETER WAS SEPARATED FROM THE RESERVOIR AND PATIENT WAS SENT TO HOSPITAL. PHYSICIAN SURGICALLY REMOVED PORT FROM SUBCUTANEOUS AREA. CATHETER UNABLE TO BE RETRIEVED. PHYSICIAN PERFORMED CARDIAC CATHETERIZATION TO ACCOMPLISH CATHETER RETRIEVAL. PROCEDURE WAS SUCCESSFUL.MARCH 14, 1992: PATIENT WAS DISCHARGED.THE CATHETER SEPARATED AFTER INSERTION INTO PATIENT. WE REQUEST THAT AN INDEPENDENT LAB TEST THE DEVICE TO DETERMINE IF IT WAS AN EQUIPMENT MALFUNCTION.DEVICE LABELED FOR SINGLE USE. PATIENT MEDICAL STATUS PRIOR TO EVENT: FAIR 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: VISUAL EXAMINATION. RESULTS OF EVALUATION: MECHANICAL PROBLEM. CONCLUSION: DEVICE FAILURE OCCURRED AND WAS RELATED TO EVENT. CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT: YES. CORRECTIVE ACTIONS: USE OF ALL SIMILAR DEVICES STOPPED PERMANENTLY. THE DEVICE WAS NOT DESTROYED/DISPOSED OF.