Description of Event or Problem · 1
PATIENT RECEIVED A PNEUMOTHORAX DURING AN INSERTION OF AN ENTRACARE ULTRAFLO NASOGASTRIC FEEDING TUBE. THE TUBE WAS INSERTED BY AN R.N. INSERTION ERROR REPORTED BY FACILITY. THE PATIENT HAD A DECREASED GAG REFLEX AND WAS NEUROLOGICALLY IMPAIRED. THE PATIENT REQUIRED CHEST TUBE INSERTION TO RESOLVE THE PNEUMOTHORAX. AS A RESULT OF THIS INCIDENT THE FACILITY HAS MODIFIED THEIR PROCEDURES FOR TUBE INSERTION. AN M.D. IS NOW REQUIRED TO PLACE NASOGASTRIC FEEDING TUBES, FOLLOWED UP WITH FLUROSCOPY OR X-RAY; M.D. TO DETERMINE.DEVICE LABELED FOR SINGLE USE. PATIENT MEDICAL STATUS PRIOR TO EVENT: UNKNOWN. 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 NOT USED AS LABELED/INDENDED.DEVICE WAS EVALUATED AFTER THE EVENT. METHOD OF EVALUATION: NONE OR UNKNOWN. RESULTS OF EVALUATION: FAILURE TO FOLLOW INSTRUCTIONS, INCORRECT TECHNIQUE/PROCEDURE. CONCLUSION: THERE WAS NO DEVICE FAILURE, USER ERROR CAUSED EVENT. CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT: MAYBE. CORRECTIVE ACTIONS: DEVICE DISCARDED, DEVICE USE CONTINUED WITH RESTRICTIONS/LIMITATIONS. THE DEVICE WAS DESTROYED/DISPOSED OF.