MEDI-PAK CLEANSING ENEMA SET

Description of Event or Problem

STUDENT NURSE INSERTED ENEMA CATHETER APPROXIMATELY 2 1/2 INCHES. THE CATHETER CAP WAS NOT REMOVED PRIOR TO INSERTION. THE CAP REMAINED IN THE RECTUM WHEN THE CATHETER WAS WITHDRAWN. THE PATIENT WAS UNABLE TO PASS THE CAP. THE PATIENT HAD A DECOMPRESSION COLONOSCOPY AND THE CAP WAS REMOVED WITHOUT PROBLEMS. THE PATIENT WOULD HAVE HAD THE DECOMPRESSION COLONSCOPY EVEN IF THIS EVENT HAD NOT OCCURRED (DUE TO MEDICAL CONDITION).DEVICE LABELED FOR SINGLE USE. PATIENT MEDICAL STATUS PRIOR TO EVENT: FAIR 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 NOT USED AS LABELED/INDENDED.DEVICE WAS NOT EVALUATED AFTER THE EVENT. METHOD OF EVALUATION: NO DATA. RESULTS OF EVALUATION: NO DATA. CONCLUSION: NO DATA. CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT: NO. CORRECTIVE ACTIONS: USER EDUCATION PROVIDED. THE DEVICE WAS DESTROYED/DISPOSED OF.