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Patient 1
DEVICE EVALUATION RESULTS: THE PSA HOOK THAT SECURES THE FRONT OF THE COLLAR TO THE BACK OF THE COLLAR HAS DETACHED. TWO POTENTIAL ROOT CAUSES HAVE BEEN IDENTIFIED, BOTH RELATED TO THE MANUFACTURING AND ASSEMBLY PROCESS. POOR PSA ADHESION MAY OCCUR IF THE CORONA TREATMENT IS INEFFECTIVE, OR IF THERE IS SURFACE CONTAMINATION ON THE HARDGOODS OR PSA. THE MOST LIKELY CAUSE FOR THE CORONA TREATMENT TO BE INEFFECTIVE IS THE DYNE TEST. THE DYNE TEST IS PART OF A SAMPLING-BASED VERIFICATION METHOD PERFORMED TO VERIFY THE EFFECTIVENESS OF THE CORONA TREATMENT. UPON PASSING THE DYNE TEST, THE PART IS CLEANED WITH ISOPROPYL ALCOHOL AND HAS THE CORONA TREATMENT REAPPLIED BEFORE BEING USED FOR PRODUCTION. TESTING PERFORMED AS PART OF THIS INVESTIGATION HAS SHOWN THAT THE PSA ADHESION ON THE DYNE TEST PARTS IS SIGNIFICANTLY LOWER THAN ON PARTS THAT WERE NOT SUBJECTED TO THE DYNE TEST. HOWEVER, WHILE INVESTIGATING THIS MATTER AT THE PRODUCTION SITE NO COMPLETE DETACHED ITEMS COULD BE IDENTIFIED. THE SECONDARY POSSIBLE ROOT CAUSE RELATES TO SURFACE CONTAMINATION. SURFACE CONTAMINATION CAN ORIGINATE ON EITHER THE HARDGOOD OR ON THE PSA. CONTAMINATION IS UNLIKELY ON THE HARDGOOD AS NO MOLD RELEASE AGENT IS USED DURING THEIR MANUFACTURING PROCESS. CONTAMINATION ON THE PSA MAY ARISE WHEN THE OPERATOR REMOVES THE PSA HOOK FROM ITS BACKING AS THEIR FINGERTIPS MAY CONTACT THE ADHESIVE. ANY INCIDENTAL CONTACT BY THE OPERATOR MAY CREATE A WEAK BOND AT THE POINT OF CONTACT. IT IS HOWEVER UNLIKELY THAT THIS WOULD CAUSE COMPLETE DETACHMENT AS THE MAJORITY OF THE PSA WILL BE FREE OF CONTAMINATION. COMPLETE DETACHMENT OF PSA HOOK IS PROBABLY CAUSED BY ACCUMULATION OF DIFFERENT CAUSES OF WEAKENING THE BOND BETWEEN THE PSA AND THE HARDGOOD. RISK ASSESSMENT FOR PRODUCTS ON THE MARKET HAS BEEN PERFORMED, TAKING INTO ACCOUNT THE TOTAL COMPLAINT RATE REGARDING THIS ISSUE SINCE 2010. PROBABILITY OF HARM HAS BEEN CALCULATED (< 1.36E-6). PER RISK CHART THIS IS AT ACCEPTABLE LEVEL. AS PER RISK CHART RISK IS ACCEPTABLE AND RISK REDUCTION IS NOT REQUIRED, NO FURTHER ACTION IS CONSIDERED WARRANTED. HOWEVER, NONCONFORMITY (B)(4) HAS BEEN CREATED TO EVALUATE THE MANUFACTURING PROCESS AND IF POSSIBLE FURTHER REDUCE THE RISK. PROCESS IMPROVEMENTS WILL BE IMPLEMENTED TO DISCARD ALL PARTS USED FOR THE DYNE TEST AND TO REDUCE THE LIKELIHOOD OF THE OPERATOR CONTAMINATING THE PSA MATERIAL. CHANGES IN THE PRODUCTION PROCESS WILL BE MANAGED THROUGH A CONTROLLED PROCEDURE.