BRACHY IMPLANT NEEDLES

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.

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: ADDITIONAL INFORMATION WAS RECEIVED, AND THE FILE WAS REASSESSED FOR REPORTABILITY AND DETERMINED TO BE NO LONGER REPORTABLE. SINCE AN INITIAL MDR WAS SUBMITTED, THEREFORE, THE FILE WILL REMAIN ASSESSED AS A MALFUNCTION. G3, H6 (DEVICE). 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.

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.