Description of Event or Problem · 1
DUE TO AN ERROR IN PACKAGING AT MANUFACTURING FACILITY, THEDRAIN BAG HAS BEEN FOLDED INCORRECTLY IN ITS POLY BAG.THE "FOLD" HAS CAUSED THE ANTI REFLUX DEVICE TO CURL SLIGHTLY, CAUSING A "STANDING COLUMN OF URINE" TO BACK UP IN THE ADJOINING TUBE. THIS PROBLEM IS TEMPORARY.DEVICE LABELED FOR SINGLE USE. PATIENT MEDICAL STATUS PRIOR TO EVENT: INVALID DATA. INVALID DATA - REGARDING 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. INVALID DATA - WHETHER DEVICE USED AS LABELED/INTENDED. INVALID DATA - REGARDING EVALUATION BY USER AFTER EVENT. METHOD OF EVALUATION: INVALID DATA. RESULTS OF EVALUATION: INVALID DATA. CONCLUSION: INVALID DATA. CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT: INVALID DATA. CORRECTIVE ACTIONS: NO DATA. INVALID DATA - ON DEVICE DESTROYED/DISPOSED OF STATUS.