NO DEVICE, NO MEDICAL RECORDS, OR NO MEDICAL IMAGES HAVE BEEN MADE AVAILABLE TO THE MANUFACTURER. AS THE LOT NUMBER FOR THE DEVICE WAS PROVIDED, A REVIEW OF THE DEVICE HISTORY RECORDS IS CURRENTLY BEING PERFORMED. THE DEVICE HAS NOT BEEN RETURNED TO THE MANUFACTURER FOR EVALUATION. THE INVESTIGATION OF THE REPORTED EVENT IS CURRENTLY UNDERWAY. THE INFORMATION PROVIDED BY BARD REPRESENTS ALL OF THE KNOWN INFORMATION AT THIS TIME. DESPITE GOOD FAITH EFFORTS TO OBTAIN ADDITIONAL INFORMATION, THE COMPLAINANT / REPORTER WAS UNABLE OR UNWILLING TO PROVIDE ANY FURTHER PATIENT, PRODUCT, OR PROCEDURAL DETAILS TO BARD.
D
Patient 1
IT WAS REPORTED THAT DURING PREP, THE VASCULAR GRAFT WAS ALLEGEDLY IDENTIFIED TO BE DIRTY; RENDERING THE DEVICE UNUSABLE. THERE WAS NO PATIENT INVOLVEMENT.
N
Patient 1
MANUFACTURING REVIEW: THE DEVICE HISTORY RECORDS HAVE BEEN REVIEWED WITH SPECIAL ATTENTION TO THE SUBASSEMBLIES, MATERIAL REVIEW REPORTS, RAW MATERIAL TESTING, MANUFACTURING PROCESS, AND QUALITY CONTROL INSPECTION. THIS LOT MET ALL RELEASE CRITERIA. THERE WAS NOTHING FOUND TO INDICATE THERE WAS A MANUFACTURING RELATED CAUSE FOR THIS EVENT. THIS IS THE ONLY COMPLAINT THAT HAS BEEN REPORTED FOR THIS CORPORATE LOT NUMBER TO DATE. VISUAL INSPECTION: THE GRAFT WAS RETURNED STILL SEALED IN THE OUTER PACKAGING OF THE DEVICE. SOME CONTAMINATES WERE NOTED ON THE OUTER PACKAGING OF THE GRAFT. IT IS UNKNOWN WHERE THE CONTAMINATES CAME FROM, THEY COULD HAVE BEEN INTRODUCED DURING THE SHIPPING OF THE DEVICE. HOWEVER, THE STERILIZED GRAFT DID NOT COME INTO CONTACT WITH THESE CONTAMINATES. NO FOREIGN MATERIAL WOULD BE ABLE TO CONTAMINATE THE GRAFT AS THE GRAFT IS STILL CONTAINED IN SEALED STERILIZED INNER CARTON OF THE PACKAGING. THE CONTAMINATION ON THE OUTER PACKAGING WOULD NOT RENDER THE DEVICE UNUSABLE. FUNCTIONAL/PERFORMANCE EVALUATION: THE SAMPLE WAS RETURNED. THE DEVICE WAS RETURNED UNUSED AND IN ITS ORIGINAL PACKAGE; THEREFORE, NO FUNCTIONAL/PERFORMANCE EVALUATION WAS REQUIRED. MEDICAL RECORDS REVIEW: MEDICAL RECORDS WERE NOT PROVIDED; THEREFORE, A REVIEW COULD NOT BE PERFORMED. IMAGE/PHOTO REVIEW: IMAGES/PHOTOS WERE NOT PROVIDED; THEREFORE, A REVIEW COULD NOT BE PERFORMED. CONCLUSION: THE INVESTIGATION IS UNCONFIRMED FOR FOREIGN MATERIAL, AS THE GRAFT HAD NO FOREIGN MATERIAL THAT WOULD COMPROMISE THE STERILITY OF THE DEVICE. CONTAMINATION WAS LOCATED ON THE EXTERNAL OUTER PACKAGING OF THE DEVICE. THEREFORE, THE INVESTIGATION IS CONFIRMED FOR ITEM CONTAMINATION OF THE OUTER PACKAGING DURING MANUFACTURING OR SHIPPING. THE CONTAMINATION THAT WAS LOCATED ON THE OUTER PACKAGING WOULD NOT EFFECT THE INTEGRITY OF STERILIZATION OF THE GRAFT CONTAINED IN THE INNER PACKAGING. NO FOREIGN MATERIAL WAS INTRODUCED TO THE GRAFT AS IT REMAINED SEALED IN THE INNER PACKAGING TRAY. THE OUTER PACKAGING CONTAMINATION COULD BE CAUSED BY THE SHIPPING OF THE DEVICE OR THE HANDLING OF THE DEVICE PRIOR TO USE. HOWEVER, THE DEFINITIVE ROOT CAUSE IS UNKNOWN. LABELING REVIEW: THE CURRENT INSTRUCTION FOR USE (IFU) STATES: WARNINGS: ALL IMPRA EPTFE VASCULAR GRAFTS ARE SUPPLIED STERILE AND NON-PYROGENIC UNLESS THE PACKAGE IS OPEN OR DAMAGED. IMPRA EPTFE VASCULAR GRAFTS ARE STERILIZED BY ETHYLENE OXIDE. OPENING THE PACKAGE: HOLD THE OUTER TRAY IN ONE HAND. PEEL BACK THE LID, REMOVE THE INNER TRAY. PEEL BACK THE INNER TRAY LID SLOWLY AND CAREFULLY REMOVE THE GRAFT USING STERILE ATRAUMATIC INSTRUMENTS OR STERILE GLOVES. THE INFORMATION PROVIDED BY BARD REPRESENTS ALL OF THE KNOWN INFORMATION AT THIS TIME. DESPITE GOOD FAITH EFFORTS TO OBTAIN ADDITIONAL INFORMATION, THE COMPLAINANT / REPORTER WAS UNABLE OR UNWILLING TO PROVIDE ANY FURTHER PATIENT, PRODUCT, OR PROCEDURAL DETAILS TO BARD.
D
Patient 1
IT WAS REPORTED THAT DURING PREP, THE VASCULAR GRAFT WAS ALLEGEDLY IDENTIFIED TO BE DIRTY; RENDERING THE DEVICE UNUSABLE. THERE WAS NO PATIENT INVOLVEMENT.