Description of Event or Problem · 1
PATIENT HAD P.E.G. INSERTED ON JANUARY 6, 1992. ON FEBRUARY 25, 1992 THE EXTERNAL PORTION OF THE TUBE WAS FOUND IN THE PATIENT'S BED. THE TUBE HAD BROKEN AWAY FROM THE RETAINING BOLSTER. A PORTION OF THE MUSHROOM WAS RETAINED IN THE STOMACH AS WELL AS THE CONNECTOR. A GASTROSCOPY WAS PERFORMED AND RETENTION BOLSTER WAS REMOVED. THE MUSHROOM TIP WAS NOT VISIBLE AND WAS EXPELLED THROUGH THE GASTROINTESTINAL TRACT ON FEBRUARY 29,1992. THE PATIENT SUFFERED NO INJURY. THE GASTROSTOMY WAS PERFORMED TO PREVENT A POSSIBLE BOWEL OBSTRUCTION FROM THE RETENTION BOLSTER AND MUSHROOM TIPDEVICE LABELED FOR SINGLE USE. 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: OTHER, OTHER, OTHER, INVALID DATA. RESULTS OF EVALUATION: NONE OR UNKNOWN, 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: INVALID DATA. CORRECTIVE ACTIONS: DEVICE RETURNED TO MANUFACTURER/DEALER/DISTRIBUTOR. THE DEVICE WAS NOT DESTROYED/DISPOSED OF.