450 SAL EJECTOR 3283

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 WHILE PERFORMING ORAL CARE, THE CAP ON THE TIP OF THE DEVICE CAME OFF AND DROPPED INTO THE PATIENT¿S MOUTH. THE CAP WAS REMOVED FROM THE PATIENT¿S MOUTH AND THE DEVICE WAS REPLACED WITH A NEW ONE. ADDITIONAL INFORMATION STATED THAT THE CAP WAS REMOVED IMMEDIATELY USING FINGERS.

Additional Manufacturer Narrative

A DEVICE HISTORY RECORD REVIEW COULD NOT BE PERFORMED BECAUSE A LOT NUMBER WAS NOT RECEIVED WITH THE COMPLAINT. 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 WITHOUT THE PACKAGE OR LOT NUMBER WAS RECEIVED AT THE MANUFACTURING SITE FOR EVALUATION. UPON A VISUAL EVALUATION OF THE SAMPLE, THE REPORTED ISSUE WAS CONFIRMED; A DETACHED BLUE CAP WAS OBSERVED. A DEFINITIVE ROOT CAUSE COULD NOT BE ESTABLISHED AT THIS TIME. HOWEVER, A GEMBA WALK WAS COMPLETED WITH THE MULTIFUNCTIONAL TEAM AND IT WAS CONCLUDED THAT THE POTENTIAL ROOT CAUSE COULD BE WORN OUT GRIPPERS AND SPRINGS. AT THE END OF THE ASSEMBLY PROCESS, A PULL TEST IS PERFORMED ON THE TUBING AND TIP ASSEMBLY AND IF THERE IS A WORN-OUT GRIPPER AND SPRINGS IT IS POSSIBLE FOR THE MACHINE TO GRAB THE TUBE INCORRECTLY. IN ORDER TO ADDRESS THIS ISSUE, THE FOLLOWING ACTIONS HAVE BEEN PERFORMED: ADDITIONAL RED RABBITS HAVE BEEN IMPLEMENTED FOR THE PULL TEST, A WORK ORDER WAS REGISTERED TO DOCUMENT THE CHANGE OF THE GRIPPERS AND SPRINGS, A WORK ORDER WAS CREATED FOR STATION CALIBRATION FROM 2 TO 5 POUNDS FOR THE PULL TEST, AND A MAINTENANCE JOB PLAN WAS CREATED. THIS COMPLAINT WILL BE USED FOR TRACKING AND TRENDING PURPOSES.