ALBOGRAFT POLYESTER VASCULAR GRAFT

Additional Manufacturer Narrative

THE PRODUCT WAS NOT AVAILABLE FOR RETURN. REVIEW OF THE AVAILABLE INFORMATION DETERMINED THE ISSUE IS DUE TO A USER ERROR. THE NURSE DID NOT PROPERLY FOLLOW THE HANDLING INSTRUCTIONS ON THE PACKAGE AND INADVERTENTLY INTRODUCED THE NON-STERILE PACKAGE INTO THE STERILE FIELD. THE IFU ALSO PROVIDES THE FOLLOWING WARNINGS RELATED TO THIS ISSUE: ALBOGRAFT VASCULAR GRAFTS ARE SUPPLIED STERILE THROUGH A DOUBLE STERILE BARRIER. THE INTERNAL CONTAINER IS EXTERNALLY STERILE PROVIDED THAT THE EXTERNAL CONTAINER HAS BEEN NEITHER DAMAGED NOR OPENED. THE EXTERNAL CONTAINER IS ONLY INTERNALLY STERILE: IT MUST NOT BE BROUGHT INTO A STERILE ENVIRONMENT. CAUTION: DO NOT BRING THE EXTERNAL CONTAINER INTO THE STERILE ENVIRONMENT. REMOVE THE GRAFT USING AN ASEPTIC PROCEDURE. WHILE THIS ISSUE WAS DETERMINED TO BE A USER ERROR, A CAPA HAS BEEN INITIATED AS A PREVENTATIVE MEASURE TO REVIEW THE DEVICE PACKAGING. REVIEW OF THE LOT HISTORY RECORD FOUND NO ISSUES FOR THIS LOT. THE DEVICE PACKAGING PROVIDES VARIOUS WARNINGS ON THE PACKAGE TO INSTRUCT THE USER HOW TO AVOID THIS ISSUE.

Description of Event or Problem

DURING A MEETING WITH THE SWEDISH MOH WE WERE INFORMED OF AN INCIDENT WHERE WHILE PREPARING THE ALBOGRAFT, THE NURSE OVERLOOKED THE LABELS ON THE PACKAGING AND INTRODUCED THE NON-STERILE PACKAGING INTO THE STERILE FIELD. THE STATUS OF THE PATIENT IS UNKNOWN. THE NURSE DID NOT REPORT THE EVENT AT THE TIME OF THE EVENT.