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Patient 1
(B)(4). INFORMATION REGARDING PATIENT AGE, WEIGHT, RACE, ETHNICITY, AND MEDICAL HISTORY WERE NOT PROVIDED. [CONCLUSION]: THE HEALTHCARE PROFESSIONAL REPORTED THAT ON (B)(6) 2018, IT WAS NOTED THAT THE STERILE PACKAGING ON THE RELIEVA SPINPLUS NAVIGATION BALLOON SINUPLASTY SYSTEM, 6 X 16 MM, 3 GUIDE KIT (RSP0616MFSN / 180409B-PC) WAS COMPROMISED. THE SEAL WAS NOTICED TO BE BROKEN; THE ISSUE WAS NOTICED PRIOR TO THE USE OF THE PRODUCT AND THE PRODUCT WAS EXCHANGED. THERE WAS NO PATIENT INVOLVEMENT. UPON FURTHER FOLLOW-UP WITH THE SALES REPRESENTATIVE, THE DEVICE WAS FROM THE SUPPLY INVENTORY AT THE CUSTOMER FACILITY. THE LOCATION OF THE REPORTED BREACH WAS FROM THE CLEAR PLASTIC BEING PULLED AWAY FROM THE TYVEK MATERIAL ON THE CHEVRON SIDE OF THE POUCH; THIS AREA COMES SEALED FROM THE SUPPLIER. IT WAS ALSO REPORTED THAT THE PRODUCT AND ITS PACKAGING WERE DISCARDED AND ARE NOT AVAILABLE TO BE RETURNED FOR INVESTIGATION. BASED ON COMPLAINT INFORMATION, THE DEVICE WAS NOT AVAILABLE TO BE RETURNED FOR ANALYSIS. A REVIEW OF MANUFACTURING DOCUMENTATION ASSOCIATED WITH THIS LOT (180409B-PC) PRESENTED NO ISSUES DURING THE MANUFACTURING OR INSPECTION PROCESSES RELATED TO THE REPORTED COMPLAINT. PRODUCT ANALYSIS CANNOT BE CONDUCTED AS THE PRODUCT WAS NOT RETURNED FOR ANALYSIS. NO DETERMINATION OF CAUSES AND POSSIBLE CONTRIBUTING FACTORS COULD BE MADE. DEVICE HISTORY REVIEW - THE LOT HISTORY RECORD(S) WAS REVIEWED AND NO ANOMALIES WERE FOUND RELATED TO THIS COMPLAINT. IN ADDITION, THE LHR REVIEW VERIFIES THAT THE DEVICE WAS MANUFACTURED IN ACCORDANCE WITH DOCUMENTED SPECIFICATION AND PROCEDURES. WITH THE INFORMATION PROVIDED IN THE COMPLAINT AND WITHOUT THE PRODUCT AVAILABLE FOR ANALYSIS, THE REPORTED ISSUE THAT THE STERILE PACKAGING WAS COMPROMISED CANNOT BE CONFIRMED. BASED ON THE LOT HISTORY RECORD (LHR) REVIEW, THERE IS NO INDICATION THAT THE EVENT IS RELATED TO THE DEVICE MANUFACTURING PROCESS. THE EXACT CAUSE OF THE COMPROMISED PACKAGING COULD NOT BE CONCLUSIVELY DETERMINED. HOWEVER, THERE ARE ADEQUATE CONTROLS IN PLACE TO PREVENT NON-SEALED POUCHES FROM BEING RELEASED. POUCH SEALS UNDERGO 100% INSPECTION AFTER SEALING; IN ADDITION, DEVICE PACKAGING INSPECTION IS PERFORMED 100% ON ALL THE POUCH SEALS BY A QUALITY TECHNICIAN. THUS, IT IS LIKELY THAT THE BREACH IN THE SEAL OF THIS POUCH OCCURRED AT THE CUSTOMER FACILITY. THE MANUFACTURER WILL SUBMIT A SUPPLEMENTAL REPORT IF NEW FACTS ARISE WHICH MATERIALLY ALTER INFORMATION SUBMITTED IN A PREVIOUS MDR REPORT. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS OF RECEIPT.