ARGYLE
Received Nov 22, 2017 · Event occurred Nov 7, 2017
Report 9612030-2017-05245 · MDR key 7053435
Device
Generic name
Mouthpiece, Saliva Ejector
Manufacturer
Mitg - KenmexModel number
8881450004Catalog number
8881450004
Product problems
- Detachment Of Device Component
- Detachment Of Device Component
Patient
Not reported
- No Consequences Or Impact To Patient
- No Consequences Or Impact To Patient
Narrative
Additional Manufacturer Narrative
ONE SAMPLE WITH UNKNOWN LOT NUMBER WAS RECEIVED FOR EVALUATION. AFTER PERFORMING AN INSPECTION, THE REPORTED ISSUE OF A TIP DETACHMENT AND ONE CRACK IN THE SALIVA EJECTOR WAS VERIFIED. DIMENSIONAL INSPECTIONS WERE PERFORMED ACCORDING TO THE SPECIFICATIONS FOR THE TUBING WITH THE FOLLOWING RESULTS: OD, SPECIFICATION 0.245 MIN TO 0.255 MAX WITH ACTUAL READING OF 0.249, ID, SPECIFICATION 0.155 MIN TO 0.165 MAX WITH ACTUAL READING OF 0.160: WITH ACCEPTABLE RESULTS. A REVIEW OF THE DEVICE HISTORY RECORD COULD NOT BE CONDUCTED BECAUSE A LOT NUMBER WAS NOT PROVIDED. A FISHBONE ANALYSIS WAS PERFORMED WITH A 6MS AND MULTIFUNCTIONAL TEAM COMPRISED BY QUALITY, MANUFACTURING ENGINEERING, MAINTENANCE ENGINEER AND OPERATION (PRODUCTION) AVAILABLE INFORMATION. THE MANUFACTURING PROCESS WAS REVIEWED DURING A WALKTHROUGH THE PROCESS. THE INVESTIGATION INCLUDED ANALYZING THE PERFORMANCE OF THE MOLD, MACHINE AND PROCESS. ACCORDING TO THE ANALYSIS THE REPORTED CONDITION OF A BROKEN PART WAS PERFORMED USING THE ACTUAL CONDITION OF THE SAMPLE; WITH THIS WE CAN CONCLUDE THAT THE MOST POTENTIAL ROOT CAUSE INDICATES THIS CONDITION COULD OCCUR DURING MOLDING PROCESS OF TIP. THE FOLLOWING CONDITIONS WERE FOUND: TOOL WITH EJECTOR PLATE DAMAGED (WORN OUT) UNBALANCE FILL IN TOOL UNBALANCE FILL IN TOOL RUNNER UNBALANCE FORMAL INVESTIGATION ACTIONS BEING TAKEN TO ADDRESS THE REPORTED CONDITION WILL BE IMPLEMENTED TO ELIMINATE THE ROOT CAUSE INCLUDE: 1.-TOOL REPAIR ACCORDING TO WORK ORDER 2.-QA ALERT AND NOTIFICATION TO PERSONNEL REGARDING THIS ISSUE TO HEIGHTEN AWARENESS. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.
Additional Manufacturer Narrative
IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.
Additional Manufacturer Narrative
SUBMIT DATE: 11/22/2017. AN INVESTIGATION IS CURRENTLY UNDER WAY; UPON COMPLETION THE RESULTS WILL BE FORWARDED. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.
Description of Event or Problem
THE CUSTOMER REPORTS THAT THE CAP CAME OFF AND IT GO INTO PATIENT THROAT AND WAS REMOVED WITH NO COMPLICATIONS REPORTED.