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Patient 1
THE DEVICE WAS NOT RETURNED FOR EVALUATION. THE LOT NUMBER IS UNKNOWN; THEREFORE, THE DEVICE HISTORY RECORD COULD NOT BE REVIEWED. THE INSTRUCTIONS FOR USE STATES THE FOLLOWING: "VISUALLY INSPECT THE PRODUCT FOR ANY IMPERFECTIONS OR SURFACE DETERIORATION PRIOR TO USE. IF PACKAGE IS OPENED OR IF ANY IMPERFECTION OR SURFACE DETERIORATION IS OBSERVED, DO NOT USE. THE URINE METER MAY BE EMPTIED IN TWO WAYS: A. TO EMPTY INTO THE BAG, GRASP THE BOTTOM OF THE METER AND LIFT UP. TO PROVIDE BETTER METER DRAINAGE, LIFTING AGAIN IS RECOMMENDED. B. TO EMPTY URINE METER INTO RECEPTACLE, TWIST GREEN PORTION OF DRAIN VALVE TO THE LEFT; TO CLOSE, TWIST GREEN PORTION OF THE DRAIN VALVE TO THE RIGHT. TO EMPTY BAG: A. REMOVE OUTLET TUBE FROM HOUSING; GENTLY SQUEEZE CONNECTOR ARMS AND PULL TUBE FROM HOUSING. B. RELEASE CLAMP AND EMPTY BAG. C. AFTER EMPTYING, RECLAMP OUTLET TUBE AND SLIDE CONNECTOR INTO HOUSING UNTIL CONNECTOR ARMS ENGAGE. EMPTY THE COLLECTION BAG REGULARLY (E.G., PRIOR TO TRANSPORT) USING A SEPARATE, CLEAN COLLECTION CONTAINER FOR EACH PATIENT. PERIODIC OBSERVATIONS OF THIS SYSTEM SHOULD BE MADE TO ENSURE THAT URINE IS FLOWING FREELY. IF A STANDING COLUMN OF URINE IS OBSERVED, CHECK FOR CORRECT POSITIONING OF BAG AND THEN FOR A PHYSICAL OBSTRUCTION. IF CORRECT POSITIONING OR REMOVAL OF PHYSICAL OBSTRUCTION DOES NOT ALLOW FREE FLOW, THE BAG MAY HAVE TO BE CHANGED." (B)(4). THE INFORMATION PROVIDED BY BARD REPRESENTS ALL OF THE KNOWN INFORMATION AT THIS TIME. DESPITE GOOD FAITH EFFORTS TO OBTAIN ADDITIONAL INFORMATION, THE COMPLAINANT / REPORTER WAS UNABLE OR UNWILLING TO PROVIDE ANY FURTHER PATIENT, PRODUCT, OR PROCEDURAL DETAILS TO BARD.