ENTERAL ADMINISTRATION Y-ADAPTER SET

Description of Event or Problem

THE ENTERAL ADMINISTRATION Y-ADAPTER SET USED IN TUBE FEED STRECTHES. THE ATTACHED PLUG DOES NOT FIT TIGHTLY, THUS WHEN GASTRIC PRESSURE BUILDS UP, THE PLUG POPS OUT ALLOWING GASTRIC CONTENTS TO FLOW FROM THE TUBE CAUSING SEVERE BURNS TO PATIENTS. THE MANUFACTURER WAS NOTIFIED AND REPLACED THE Y-ADAPTER SET WITH TWIN-PORT UNIVERSAL Y-ADAPTERDEVICE LABELED FOR SINGLE USE. PATIENT MEDICAL STATUS PRIOR TO EVENT: FAIR CONDITION. THERE WAS MULTIPLE PATIENT INVOLVEMENT. NUMBER OF PATIENTS INVOLVED: 2.DEVICE NOT SERVICED IN ACCORDANCE WITH SERVICE SCHEDULE. 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: OTHER, OTHER, OTHER, INVALID DATA. RESULTS OF EVALUATION: INVALID DATA, INVALID DATA, INVALID DATA, INVALID DATA. CONCLUSION: DEVICE FAILED DURING ASSEMBLY, DEVICE FAILED DURING ASSEMBLY, OTHER, OTHER. CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT: YES. CORRECTIVE ACTIONS: USE OF ALL SIMILAR DEVICES STOPPED PERMANENTLY, INVALID DATA, INVALID DATA. INVALID DATA - ON DEVICE DESTROYED/DISPOSED OF STATUS.