NS-3631 N-STER DISPOSABLE

Additional Manufacturer Narrative

TWO PHOTOGRAPHS WERE SUBMITTED FOR EVALUATION. A SAMPLE ANALYSIS WAS PERFORMED USING THE PICTURES AND IT APPEARS THAT THE LITE SLEEVE IS RIPPED. DURING A WALK THROUGH THE PRODUCTION LINE TO DETECT POTENTIAL CAUSES, IT WAS OBSERVED THAT ALL PROCEDURES ARE BEING FOLLOWED ACCORDINGLY. THE DEVICE HISTORY RECORD (DHR) WAS REVIEWED, AND NO ABNORMAL PROCESS CONDITIONS WERE PRESENT DURING THE MANUFACTURING OF THE PRODUCT THAT COULD HAVE LED TO THE CONDITION DESCRIBED BY THE CUSTOMER. THE DHR REVIEW SHOWED THAT ALL ACCEPTANCE CRITERIA INSPECTIONS PER ESTABLISHED SAMPLING LEVELS WERE WITHIN ACCEPTABLE LIMITS DURING THE PRODUCTION PROCESS. : THE INVESTIGATION WAS PERFORMED ANALYZING THE PERFORMANCE OF THE MOLDS, MACHINE AND PROCESS. ACCORDING THE ANALYSIS THE ISSUE WAS NOT REPRODUCED BUT DID IDENTIFIED POSSIBLE CONDITIONS THAT COULD PRODUCE THE REPORTED CONDITION. WE CAN CONCLUDE THAT THE MOST LIKELY ROOT CAUSE INDICATES THIS CONDITION COULD OCCUR DURING THE MOLDING PROCESS SINCE THESE PARTS COULD GET STUCK INTO THE MOLD CAVITY (NEST) DUE TO A SIMILAR COOLING TEMPERATURES FROM BOTH MOLD SIDES, THIS CONDITION GENERATES THAT THE PARTS GET STUCK ON THE STATIONARY SIDE OF THE MOLD IN ORDER TO REMOVE THE STUCK PART THE PART NEEDS TO BE CUT IN ORDER TO BREAK THE VACUUM BETWEEN THE PART AND MOLD, SOME OF THESE PARTS WERE MIXED WITH THE APPROVED MATERIAL, SINCE THE MOLDING CONDITIONS GENERATE THE STUCK MATERIAL THE EJECTION OF THE PART WHICH DEPENDS TOTALLY TO THE AIR POPPET EXTRACTION SYSTEM. NEW POTENTIAL ROOT CAUSES ARE UNDER INVESTIGATION AND ATTRIBUTED TO: THE BLEND OF RAW MATERIAL (EXCESS OF PIGMENT OR EXCESS OF REGRIND) AND THE TOOL ALIGNMENT BETWEEN THE 2 HALF SIDES OF THE TOOL. (CAUSING STRESS TO THE ZONE BETWEEN THE ROD AND DOME OF THE PART). THE FOLLOWING CORRECTIVE /PREVENTATIVE ACTIONS (CAPA) WERE IMPLEMENTED AND DOCUMENTED UNDER THE CHANGE DEVELOPMENT PROCESS (CDP): THE PROCESS WAS VALIDATED TO CONFIRM AND ACHIEVE OPTIMAL PROCESS CONDITIONS (MOLD, MACHINE, AIR SYSTEM, ETC.). THE FIRST LOT NUMBER MANUFACTURED AFTER IMPLEMENTATION OF THESE CORRECTIVE ACTIONS WAS (B)(4).

Additional Manufacturer Narrative

AN INVESTIGATION IS CURRENTLY UNDERWAY. UPON COMPLETION, THE RESULTS WILL BE FORWARDED.

Description of Event or Problem

IT WAS REPORTED TO COVIDIEN ON (B)(6) 2016 THAT A CUSTOMER HAD AN ISSUE WITH A LITE GLOVE. THE CUSTOMER STATES THAT THE LITE GLOVES WERE CRACKED WHEN OPENED FOR USE.