450 SAL EJECTOR 3283

Additional Manufacturer Narrative

AS PART OF OUR MANUFACTURING PROCESS, ALL DEVICE HISTORY RECORDS ARE REVIEWED AND APPROVED BY QUALITY, PRIOR TO THE RELEASE OF PRODUCT. ONE DECONTAMINATED SAMPLE WAS RECEIVED AT THE MANUFACTURING SITE FOR EVALUATION WITHOUT THE ORIGINAL PACKAGING OR LOT NUMBER. UPON A VISUAL EVALUATION OF THE SAMPLE, IT WAS IDENTIFIED THAT ONLY A DEFORMED BLUE CAP WAS RETURNED. FOR THIS REASON, FUNCTIONAL EVALUATIONS COULD NOT BE PERFORMED, AND THE REPORTED ISSUE COULD NOT BE CONFIRMED. A GEMBA WALK WAS COMPLETED WITH THE MULTIFUNCTIONAL TEAM AT THE MANUFACTURING SITE AND IT HAS BEEN DETERMINED THAT THE POTENTIAL ROOT CAUSE FOR THE REPORTED ISSUE COULD BE WORN OUT GRIPPERS AND SPRINGS. AT THE END OF THE ASSEMBLY PROCESS A PULL TEST IS PERFORMED ON THE TUBING AND THE TIP ASSEMBLY, IF THERE IS A WORN-OUT GRIPPER AND SPRINGS IT IS POSSIBLE FOR THE MACHINE TO GRAB THE TUBE INCORRECTLY. AS PART OF CONTINUOUS IMPROVEMENTS, THE FOLLOWING ACTIONS WERE PERFORMED TO ADDRESS THE REPORTED ISSUE: INCLUDED ADDITIONAL RED RABBITS, PULL TEST. WORK ORDER REGISTERED TO DOCUMENT THE CHANGED GRIPPERS AND SPRINGS. WORK ORDER FOR STATION CALIBRATION FROM 2 TO 5 POUNDS FOR PULL TEST. A MAINTENANCE JOB PLAN WAS CREATED. THIS COMPLAINT WILL BE USED FOR QA TRACKING AND TRENDING PURPOSES.

Additional Manufacturer Narrative

THE INCIDENT SAMPLE HAS BEEN REQUESTED BUT TO DATE HAS NOT BEEN RECEIVED FOR EVALUATION. IF THE SAMPLE IS RECEIVED, OR IF ADDITIONAL INFORMATION PERTINENT TO THE INCIDENT IS OBTAINED A FOLLOW-UP REPORT WILL BE SUBMITTED.

Description of Event or Problem

THE CUSTOMER REPORTED THAT AFTER INTRAORAL SUCTION, THE TUBE PART WAS ABLE TO BE DISCARDED INTO THE WASTE BIN, HOWEVER, THE TIP PART CAME OFF AND WAS NOT PUT INTO THE WASTE BIN. THERE WAS NO PATIENT HARM REPORTED BECAUSE THE EVENT OCCURRED AFTER USE.