Description of Event or Problem · 1
THE PATIENT HAD AN ALLERGIC REACTION CONSISTING OF WATERY AND RED EYES, RUNNY NOSE, SNEEZING, AND A QUESTION OF DIFFICULTY BREATHING. THIS REACTION OCCURRED DURING A BARIUM ENEMA EXAMINATION. THE PATIENT INFORMED THE TECHNOLOGIST OF HER HISTORY OF ALLERGIC REACTIONS TO LATEX PRODUCTS ONLY AFTER THE EXAM WAS COMPLETED. THE PRODUCT USED WAS A DUAL FLEX ENEMA TIP.AT THE TIME OF THIS EXAMINATION, IT WAS THOUGHT THAT THE PRODUCT DID NOT CONTAIN LATEX. THE PACKAGING DID NOT SPECIFY THAT LATEX WAS A COMPONENT. AFTER CONTACTING THE MANUFACTURER IT WAS FOUND THAT THE PARTICULAR LOT NUMBER USED WAS AN OLD PRODUCT, AND BECAUSE OF THIS, THE PRODUCT DID CONTAIN LATEX. THE MANUFACTURER HAS CHANGED ITS PROCESSING PROCEDURES SINCE THAT TIME. ALL REMAINING ENEMA TIPS WERE RETURNED TO THE MANUFACTURER. THE PATIENT WAS TREATED BY A LOCAL NURSE PRACTIONER. SHE WAS GIVEN CORTISONE I.M. AT THAT TIME, FOLLOWED BY THREE DAYS OF PREDNISONEDEVICE 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: VISUAL EXAMINATION. RESULTS OF EVALUATION: PATIENT DIAGNOSIS CONTRAINDICATED USE OF DEVICE. CONCLUSION: THERE WAS NO DEVICE FAILURE. CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT: YES. CORRECTIVE ACTIONS: DEVICE RETURNED TO MANUFACTURER/DEALER/DISTRIBUTOR. THE DEVICE WAS DESTROYED/DISPOSED OF.