| Seq | Brand | Generic | Manufacturer | Product code | Model | Catalog | Lot | PMA | 510(k) | Implant | Evaluated | Availability |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | BRACHYSOURCE SEED IMPLANTS LOADED IN DISPOSABLE SHEILDED MICK MAGAZINES | BRACHYSOURCE IODINE 125 SEED | BARD BRACHYTHERAPY, INC. -1424526 | KXK | PS-1251CCE | UNK | Y | R |
| Sequence | Received | Treatment | Outcome |
|---|---|---|---|
| 1 | 2016-07-22 | 0 |
Patient 1
THE INVESTIGATION IS STILL IN PROGRESS. ONCE THE INVESTIGATION IS COMPLETE A SUPPLEMENTAL REPORT WILL BE FILED. 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.
Patient 1
IT WAS REPORTED THAT THE QUALITY ENGINEER DISCOVERED A LEAKAGE OF A SOURCE. IT WAS ALSO REPORTED THAT 12 SOURCES WERE BEING TRANSFERRED FROM 1 CONTAINER TO ANOTHER. THE WORKSPACE WAS CHECKED AND RADIATION CONTAMINATION WAS DETECTED. IT WAS INITIALLY THOUGHT TO BE TECHNETIUM, BUT AFTER A FEW DAYS THERE WAS STILL ACTIVITY. EVERY SOURCE WAS CHECKED BY RUBBING THEM AGAINST TISSUE. ONE OF THE SOURCES CONTAMINATED THE TISSUE.
Patient 1
THE INVESTIGATION IS STILL IN PROGRESS. ONCE THE INVESTIGATION IS COMPLETE A SUPPLEMENTAL REPORT WILL BE FILED. 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.
Patient 1
IT WAS REPORTED THAT THE QUALITY ENGINEER DISCOVERED A LEAKAGE OF A SOURCE. IT WAS ALSO REPORTED THAT 12 SOURCES WERE BEING TRANSFERRED FROM 1 CONTAINER TO ANOTHER. THE WORKSPACE WAS CHECKED AND RADIATION CONTAMINATION WAS DETECTED. IT WAS INITIALLY THOUGHT TO BE TECHNETIUM, BUT AFTER A FEW DAYS THERE WAS STILL ACTIVITY. EVERY SOURCE WAS CHECKED BY RUBBING THEM AGAINST TISSUE AS SHOWN IN THE INCLUDED VIDEO THAT IS ATTACHED. ONE OF THE SOURCES CONTAMINATED THE TISSUE.
Patient 1
THE INVESTIGATION IS STILL IN PROGRESS. ONCE THE INVESTIGATION IS COMPLETE A SUPPLEMENTAL REPORT WILL BE FILED. 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.
Patient 1
IT WAS REPORTED THAT THE QUALITY ENGINEER DISCOVERED A LEAKAGE OF A SOURCE. IT WAS ALSO REPORTED THAT 12 SOURCES WERE BEING TRANSFERRED FROM 1 CONTAINER TO ANOTHER. THE WORKSPACE WAS CHECKED AND RADIATION CONTAMINATION WAS DETECTED. IT WAS INITIALLY THOUGHT TO BE TECHNETIUM, BUT AFTER A FEW DAYS THERE WAS STILL ACTIVITY. EVERY SOURCE WAS CHECKED BY RUBBING THEM AGAINST TISSUE AS SHOWN IN THE INCLUDED VIDEO THAT IS ATTACHED. ONE OF THE SOURCES CONTAMINATED THE TISSUE.
Patient 1
THE INVESTIGATION IS STILL IN PROGRESS. ONCE THE INVESTIGATION IS COMPLETE A SUPPLEMENTAL REPORT WILL BE FILED. 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.
Patient 1
IT WAS REPORTED THAT THE QUALITY ENGINEER DISCOVERED A LEAKAGE OF A SOURCE. IT WAS ALSO REPORTED THAT 12 SOURCES WERE BEING TRANSFERRED FROM 1 CONTAINER TO ANOTHER. THE WORKSPACE WAS CHECKED AND RADIATION CONTAMINATION WAS DETECTED. IT WAS INITIALLY THOUGHT TO BE TECHNETIUM, BUT AFTER A FEW DAYS THERE WAS STILL ACTIVITY. EVERY SOURCE WAS CHECKED BY RUBBING THEM AGAINST TISSUE AS SHOWN IN THE INCLUDED VIDEO THAT IS ATTACHED. ONE OF THE SOURCES CONTAMINATED THE TISSUE.
Patient 1
THREE CONTAINERS WERE RETURNED FROM THE CUSTOMER. THE REPORTED EVENT WAS CONFIRMED; HOWEVER, THE CAUSE IS UNKNOWN. THE FIRST CONTAINER WAS SLIGHTLY CONTAMINATED ON THE OUTSIDE; WHEN OPENED, IT WAS EMPTY. THE SECOND CONTAINER WAS ALSO SLIGHTLY CONTAMINATED ON THE OUTSIDE; WHEN OPENED, THERE WAS A SINGLE SEED PRESENT. A SWIPE OF THE SEED DETECTED CONTAMINATION. THE INSIDE LID OF THIS CONTAINER WAS ALSO SLIGHTLY CONTAMINATED. THE THIRD CONTAINER CONTAINED 25 SEEDS; NO CONTAMINATION WAS DETECTED. BASED ON THE SWIPE OF THE SINGLE, ISOLATED SEED WHICH DETECTED CONTAMINATION, THIS SEED IS CONFIRMED TO BE LEAKING. HOWEVER, WHEN THIS LEAKAGE OCCURRED IS UNKNOWN. THE DEVICE HISTORY RECORD WAS REVIEWED AND FOUND NOTHING THAT COULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED EVENT. THE INSTRUCTIONS FOR USE STATE THE FOLLOWING: "THE SECTION ENTITLED "WARNINGS AND PRECAUTIONS" DIRECTS THE HEALTHCARE PROFESSIONALS TO INITIATE RADIATION SURVEYS ON ALL COMPONENTS UPON COMPLETION OF THE SEED IMPLANT. ADDITIONALLY, THE SECTION ENTITLED "WARNING: NEVER IMPLANT VISIBLY DAMAGED BRACHYSOURCE SEED IMPLANTS" DESCRIBES HOW TO HANDLE THE SEEDS AND WHAT WILL OCCUR SHOULD SUCH FORCE DAMAGE THE SOURCE. LASTLY, THE SECTION ENTITLED "ACCIDENTAL DAMAGE" DESCRIBES STEPS TO BE TAKEN SHOULD DAMAGE OCCUR TO THE BRACHYSOURCE SEEDS." (B)(4). 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.
Patient 1
IT WAS REPORTED THAT THE QUALITY ENGINEER DISCOVERED LEAKAGE OF A SOURCE. IT WAS ALSO REPORTED THAT 12 SOURCES WERE BEING TRANSFERRED FROM 1 CONTAINER TO ANOTHER. THE WORKSPACE WAS CHECKED AND RADIATION CONTAMINATION WAS DETECTED. IT WAS INITIALLY THOUGHT TO BE TECHNETIUM, BUT AFTER A FEW DAYS THERE WAS STILL ACTIVITY. EVERY SOURCE WAS CHECKED BY RUBBING THEM AGAINST TISSUE AS SHOWN IN THE VIDEO THAT IS ATTACHED TO THE COMPLAINT. IT WAS NOTED THAT ONE OF THE SOURCES CONTAMINATED THE TISSUE.