Description of Event or Problem · 1
THE SUCKER WAS PLACED INTO THE CHEST OF A PT HAVING OPEN HEART SURGERY. WHEN THE SUCKER WAS REMOVED FROM CHEST, IT WAS NOTED THAT THE TIP WAS NOT ON THE SUCKER. A SECOND SUCKER OF THE SAME LOT NUMBER WAS PLACED INTO THE CHEST CAVITY, AND WHEN REMOVED FROM THE CHEST ONE HOUR LATER, THE TIP APPEARED TO BE BROKEN OFF. ONE TIP WAS FOUND VIA MANUAL EXPLORATION OF THE CHEST CAVITY. THE SECOND TIP WAS NOT LOCATED. THE DEVICE IS NOT RADIOPAQUE.DEVICE 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.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: COMPONENT FAILURE, TELEMETRY FAILURE, OTHER. CONCLUSION: DEVICE FAILURE OCCURRED BUT NOT RELATED TO EVENT. CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT: INVALID DATA. CORRECTIVE ACTIONS: DEVICE TEMPORARILY REMOVED FROM SERVICE, USE OF ALL SIMILAR DEVICES STOPPED TEMPORARILY. INVALID DATA - ON DEVICE DESTROYED/DISPOSED OF STATUS.