DISPOSABLE SALIVA EJECTOR

Description of Event or Problem

THIS REPORT IS BEING SUBMITTED BECAUSE THE TIP OF A HEALTH CO. DISPOSABLE SALIVA EJECTOR REPORTABLY BROKE OFF INTO A PATIENT'S MOUTH AND WAS NOT RECOVERED. THE DEVICES HAVE BEEN REMOVED FROM PATIENT CARE UNTIL FURTHER NOTICE OR RECOMMENDATION BY THE MANUFACTURER. THE PATIENT WAS IN CRITICAL CONDITION WITH AN ADMITTING DIAGNOSIS OF A FACE AND NECK MUCAL EPIDERMOID CARCINOMA. THE MEDICAL STAFF WERE SUCTIONING THE PATIENT USING THE HEALTH CO. DISPOSABLE SALVIA EJECTOR. WHEN THE PROCEDURE WAS COMPLETED , IT WAS NOTED THAT THE TIP OF THE DEWVICE WAS MISSING. BECAUSE THE PATIENT HAD A LARGE OPEN WOUND DUE TO THE CANCEROUS LESION MASS, LOCATING THE MISSING TIP WAS NOT SUCCESSFUL. THE PATIENT LATER EXPIRED BUT NOT THE RESULT OF THE DISLODGED TIP. THE FINAL DIAGNOSIS FOR THE PATIENT WAS MUCAL EPIDERMOID CARCINOMA ON THE PATIENT'S RIGHT SIDE OF THE NECK AND FACE, COMPLECATED BY PNEUMONIA AND ADULT RESPIRATORY DISTRESS SYNDROME, LEFT SUBCLAVIAN THROMBOSIS, AND LEFT ARTERIAL INJURY. THE FAMILY DECLINED TO HAVE AN AUTOPSY PERFORMEDDEVICE NOT 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: A DEVICE FROM SAME LOT WAS EVALUATED, PERFORMANCE TESTS PERFORMED, VISUAL EXAMINATION. RESULTS OF EVALUATION: COMPONENT FAILURE. CONCLUSION: DEVICE FAILURE DIRECTLY CAUSED EVENT. CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT: YES. CORRECTIVE ACTIONS: DEVICE TEMPORARILY REMOVED FROM SERVICE, NONE OR UNKNOWN. THE DEVICE WAS DESTROYED/DISPOSED OF.