PHASIX MESH

Description of Event or Problem

AS REPORTED, A PHASIX MESH WAS PULLED FROM HOSPITAL INVENTORY FOR A VENTRAL HERNIA REPAIR PROCEDURE, AND IT WAS NOTED THAT THE INNER STERILE PACKAGING WAS DAMAGED, AND THE STERILITY WAS COMPROMISED. THE MESH WAS NOT USED. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE. THERE WAS NO PATIENT IMPACT AS A RESULT OF THIS EVENT.

Additional Manufacturer Narrative

AS REPORTED, THE PHASIX MESH INNER STERILE PACKAGING WAS DAMAGED, AND THE STERILITY WAS COMPROMISED. THE EVALUATION OF THE DEVICE FINDS DAMAGE TO THE OUTER CARTON AND TO THE INNER POUCH. THE DAMAGE TO THE OUTER CARTON ALIGNS WITH THE DAMAGE TO THE INNER POUCH. EVALUATION SHOWS THE PRODUCT CARTON WAS IMPACTED AT SOME POINT IN TRANSIT OR STORAGE. THIS RESULTED IN DAMAGE TO THE CARTON CAUSING AN OUTSIDE IN TEAR OF THE FOIL POUCH BREACHING THE STERILE BARRIER. REVIEW OF MANUFACTURING RECORDS CONFIRMS PRODUCT WAS MANUFACTURED TO SPECIFICATION, WITH NO INDICATION OF A MANUFACTURING RELATED CAUSE FOR THE EVENT REPORTED. TO DATE, THIS IS THE ONLY REPORTED COMPLAINT FOR THIS MANUFACTURING LOT OF (B)(4) UNITS. NOTE: SECTION A THROUGH F - THE INFORMATION PROVIDED BY BD 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 BD."