BRACHY IMPLANT NEEDLES

Description of Event or Problem

ON (B)(6) 2025, A PATIENT WAS UNDERGOING A BRACHYTHERAPY PROCEDURE. BEFORE USE OF THE NEEDLE, IT WAS REPORTED THAT THE PINK PART OF THE BRACHY NEEDLE STYLET OR CANNULA HAD A SHAPE DEFECT. THERE WAS NO PATIENT CONTACT.

Additional Manufacturer Narrative

H11: AS THE LOT NUMBER FOR THE DEVICE WAS NOT PROVIDED, A REVIEW OF THE DEVICE HISTORY RECORDS COULD NOT BE PERFORMED. THE DEVICE HAS BEEN RETURNED TO THE MANUFACTURER FOR EVALUATION. THE INVESTIGATION OF THE REPORTED EVENT IS CURRENTLY UNDERWAY. SECTION A THROUGH F ¿ THE INFORMATION PROVIDE BY BD REPRESENTS ALL 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.