THE SUBJECT PRODUCT WAS RETURNED FOR EVALUATION AND VISUALLY INSPECTED. THE PEG GLASS CARTRIDGE AND THE ALBUMIN GLASS CARTRIDGE WERE BOTH RECEIVED PHYSICALLY FRACTURED AT THE PROXIMAL PUSH ROD ENTRY POINTS. THE SECOND GLASS CARTRIDGE WAS BROKEN, WITH A FRAGMENT MISSING AND NOT RETURNED. THE CONTACT REPORTED THAT THE VIAL CRACKED AND NO LOOSE FRAGMENTS WERE REPORTED TO HAVE COME FREE FROM THE DEVICE. THERE ARE MULTIPLE WAYS THAT THE CARTRIDGES COULD HAVE BECOME CRACKED DURING MANUFACTURING AND POST MANUFACTURING OF THE PRODUCT. THERE WERE NO SIGNS OF DAMAGE TO THE PUSH ROD OR OTHER COMPONENTS TO INDICATE EXCESSIVE FORCE AND NO DAMAGE WAS REPORTED AT THE BEGINNING OF USE. A LOT NUMBER WAS NOT PROVIDED, THEREFORE, A MANUFACTURING REVIEW COULD NOT BE PERFORMED. AT THIS TIME, WE ARE UNABLE TO REACH A DEFINITIVE CONCLUSION AS TO WHEN AND HOW THE VIALS WERE DAMAGED. THE IFU FOR THE PROGEL PRODUCT PRESCRIBES THE PROPER INSTRUCTIONS AND PRECAUTIONS FOR THIS DEVICE TO INSPECT FOR DAMAGE TO THE PRODUCT AND TO PREVENT DAMAGE TO THE PRODUCT DURING USE. 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
AS REPORTED BY THE DAVOL SALES REP: DURING A ROBOTIC THORACIC LUNG RESECTION, THE OR TECH PREPARED THE PROGEL USING PROPER TECHNIQUE. AS THE SURGEON SPRAYED THE PROGEL ONTO THE LUNG, IT WAS NOTED THAT THE LIQUID WAS COMING OUT INTO THE APPLICATOR HOUSING OF THE DEVICE AND NOTED THAT THE VIAL WITHIN THE APPLICATOR HOUSING HAD CRACKED. THERE WERE NO LOOSE FRAGMENTS WITHIN THE APPLICATOR AND NOTHING HAD COME FREE FROM THE DEVICE. ANOTHER PROGEL WAS PREPARED AND USED WITHOUT FURTHER ISSUE RESULTING IN ONLY A VERY SHORT DELAY TO THE CASE. SURGEON NOTED A SLIGHT RESISTANCE WHEN BEGINNING TO SPRAY ; HOWEVER, NOTED IT IS NOT UNUSUAL TO HAVE A SLIGHT RESISTANCE BEFORE THE PROGEL IS RELEASED. THE VIAL WAS NOT IDENTIFIED AS HAVING BEEN DAMAGED AT THAT TIME. THERE WAS NO PATIENT INJURY AS A RESULT OF THE EVENT.