BAXJECT II HI-FLOW NEEDLESS TRANSFER DEVICE

Additional Manufacturer Narrative

THE SAMPLE HAS BEEN RETURNED AND IS PENDING INVESTIGATION.

Description of Event or Problem

THE PHYSICIAN FOLLOWED THE USUAL RECONSTITUTION PROCEDURE FOR ADZYNMA, BUT IN TWO OF THE VIALS, THE DILUENT DID NOT FLOW DOWN INTO THE PRODUCT VIAL. SINCE TWO PRODUCTS WERE AFFECTED, THE PHYSICIAN HAS REQUESTED AN INVESTIGATION INTO THE CAUSE. IN ADDITION, SOME SOLUTION ALWAYS REMAINS IN THE PRODUCT VIAL DURING THE RECONSTITUTION PROCESS. SINCE THE PHYSICIAN WAS UNABLE TO PERFORM THE RECONSTITUTION PROCEDURE, IT WAS CARRIED OUT USING THEIR SYRINGE NEEDLE INSTEAD OF RECONSTITUTION DEVICE BASED ON THEIR OWN JUDGMENT, AND THE PRODUCT HAS ALREADY BEEN ADMINISTERED TO THE PATIENT ((B)(6)). AS SHOWN IN THE SAMPLE PHOTO, THE COMPONENTS WERE SEPARATED, AND THE STOPPER PORTION WAS PUNCTURED MULTIPLE TIMES WITH A SYRINGE AT THE HOSPITAL THE PHYSICIAN UNDERSTANDS THAT THE PRODUCT SOLUTION IS DESIGNED TO CONTAIN AN EXCESS AMOUNT TO COMPENSATE FOR THIS BUT IS STILL CONCERNED ABOUT WHETHER THE PRESCRIBED DOSE IS ACTUALLY BEING ADMINISTERED. THEREFORE, THEY HAD REQUEST TO KNOW THE APPROXIMATE RESIDUAL LIQUID VOLUME REMAINING IN THE PRODUCT VIAL AFTER RECONSTITUTION, SUCH AS MEASUREMENT THE ACTUAL RESIDUAL VOLUME, IN ML, REMAINING IN THE PRODUCT VIAL AFTER RECONSTITUTION WITH THE COMPLAINT PHYSICAL SAMPLE.