THERASEED IN MICK CARTRIDGES, STERILE
Report
- Report Number
- 1018233-2016-01756
- Event Type
- Malfunction
- Date Received
- December 6, 2016
- Report Date
- December 27, 2016
- Manufacturer
- BARD BRACHYTHERAPY, INC. -1424526
- Product Code
- KXK
- PMA / PMN Number
- K060636
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MD, US
- Reporter Occupation
- HEALTH PROFESSIONAL
Narratives
THE INVESTIGATION IS STILL IN PROGRESS. ONCE THE INVESTIGATION IS COMPLETE A SUPPLEMENTAL REPORT WILL BE FILED. 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.
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.
BASED ON THE RETURNED SAMPLE, THE COMPLAINT WAS CONFIRMED; HOWEVER, IT IS UNKNOWN HOW AND WHEN THE SEEDS BECAME DISLODGED FROM THE CARTRIDGE. SEVEN MICK CARTRIDGES WERE RETURNED IN A SHIELDED CONTAINER - 6 CARTRIDGES LOADED WITH 15 SEEDS, AND 1 CARTRIDGE WAS A PARTIAL (I.E. LESS THAN 15 SEEDS). THE LATTER CARTRIDGE WAS ASSOCIATED WITH THE CUSTOMER'S ALLEGATION. IT WAS OBSERVED THAT 2 SEEDS WERE CONTAINED WITHIN THE 4ML VENTED VIAL WHICH ACCOMPANIED THE SHIELDED CONTAINER. THERE WAS ONE SEED IN THE CARTRIDGE. THE MAGAZINE HEAD WAS FULLY SCREWED ON, AND NOTHING UNUSUAL WAS NOTED. AFTER REMOVING ALL CONTENTS FROM THE SHIELDED CONTAINER, THE RATE METER INDICATED MORE RADIOACTIVITY WITHIN THE SHIELDED CONTAINER. THE INSERT WAS REMOVED AND ANOTHER SEED WAS FOUND ALONG THE BOTTOM EDGE. THE FOUR SEEDS WERE LOADED INTO THE CARTRIDGE AND THE MAGAZINE HEAD FULLY TIGHTENED. ALL SEEDS WERE HELD SECURELY IN THE CARTRIDGE AND NONE FELL OUT. WITH ALL SEEDS REMOVED, THE MAGAZINE SHIELD WAS EXAMINED WITH THE MICRO-VU, EQUIPMENT, AND NOTHING UNUSUAL WAS NOTED. ATTEMPTS TO RECREATE THE FAILURE MODE WITH NON-RADIOACTIVE I-125 SEEDS WERE MADE. WHEN 4 SEEDS WERE LOADED INTO THE CARTRIDGE AND THE MAGAZINE HEAD FULLY SCREWED ON, THE SPRING TENSION WAS SUFFICIENT FOR KEEPING THE SEEDS IN THE CARTRIDGE. THE MAGAZINE HEAD NEEDED TO BE SCREWED ON APPROXIMATELY HALF-WAY IN ORDER FOR SEEDS TO FALL OUT OF THE CARTRIDGE. THIS WAS NOT OBSERVED WITH THE RETURNED SAMPLE. THE LOT NUMBER IS UNKNOWN; THEREFORE, THE DEVICE HISTORY RECORD COULD NOT BE REVIEWED. HOWEVER, THE CUSTOMER ORDER RELEASE DOCUMENTATION FOR SALES ORDER # (B)(4) WAS RETRIEVED AND REVIEWED. THE CUSTOMER ORDER CALLED FOR A QUANTITY OF 7 MICK 15 CARTRIDGES - 6 CARTRIDGES LOADED WITH 15 PALLADIUM-103 SEEDS AND 1 CARTRIDGE LOADED WITH 4 PALLADIUM-103 SEEDS FOR A TOTAL OF 94 SEEDS. THESE SEEDS WERE SUPPLIED BY (B)(4), A BBI APPROVED SUPPLIER OF PALLADIUM-103 SEEDS. BECAUSE THESE SEEDS WERE NOT MANUFACTURED BY (B)(4), A DEVICE HISTORY RECORD REVIEW COULD NOT BE PERFORMED. WHEN PALLADIUM-103 SEEDS ARE REQUIRED FOR A CUSTOMER ORDER, A VERIFICATION OF THE SEED QUANTITY IS PERFORMED. FOR THIS ORDER, THE SEED QUANTITY WAS VERIFIED TO BE CORRECT DURING ORDER FILLING ACTIVITIES. THE INSTRUCTIONS FOR USE STATE THE FOLLOWING: "THERE IS A WARNING NOT TO HANDLE THE MAGAZINE HEAD BY THE SPRING-LOADED PLUNGER. HANDLING BY THE PLUNGER COULD REMOVE THE SPRING TENSION FROM THE SEEDS AND CAUSE THEM TO FALL OUT OF THE CARTRIDGE. ADDITIONALLY, THERE IS INSTRUCTION THAT THE MAGAZINE IS NOT DESIGNED TO SCREW INTO OR OUT OF THE APPLICATOR. THE IFU FURTHER DESCRIBES THAT THE OUTSIDE THREADS ARE TO BE USED TO AFFIX MAGAZINES TO THE SEED STERILIZED BLOCK AND THE V-BLOCK FOR SEED LOADING." (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.
IT WAS REPORTED THAT THE FACILITY FOUND 2 SEEDS IN A CARTRIDGE AND 1 SEED STUCK IN THE CONTAINER. AS A RESULT, THE FACILITY ALLEGED THAT THEY ONLY RECEIVED 91, OF THE 94, PD103 SEEDS THAT WERE ORDERED. ALL OF THE SEEDS HAVE NOW BEEN ACCOUNTED FOR WITH THEIR RECEIVED ORDER. IT WAS LATER REPORTED THAT THE PATIENT HAD TO BE RESCHEDULED DUE TO THE SEEDS STICKING.
IT WAS REPORTED THAT THE FACILITY FOUND 2 SEEDS IN A CARTRIDGE AND 1 SEED STUCK IN THE CONTAINER. AS A RESULT, THE FACILITY ALLEGED THAT THEY ONLY RECEIVED 91, OF THE 94, (B)(6)SEEDS THAT WERE ORDERED. ALL OF THE SEEDS HAVE NOW BEEN ACCOUNTED FOR WITH THEIR RECEIVED ORDER. IT WAS LATER REPORTED THAT THE PATIENT HAD TO BE RESCHEDULED DUE TO THE SEEDS STICKING.
IT WAS REPORTED THAT THE FACILITY FOUND 2 SEEDS IN A CARTRIDGE AND 1 SEED STUCK IN THE CONTAINER. AS A RESULT, THE FACILITY ALLEGED THAT THEY ONLY RECEIVED 91, OF THE 94, PD103 SEEDS THAT WERE ORDERED. ALL OF THE SEEDS HAVE NOW BEEN ACCOUNTED FOR WITH THEIR RECEIVED ORDER. IT WAS LATER REPORTED THAT THE PATIENT HAD TO BE RESCHEDULED DUE TO THE SEEDS STICKING.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 797884 | THERASEED IN MICK CARTRIDGES, STERILE | PD103 SEEDS | KXK | BARD BRACHYTHERAPY, INC. -1424526 | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |