I125 SEEDS IN QUICKLINK, STERILE, 13.1 MBQ
Report
- Report Number
- 1018233-2025-11636
- Event Type
- Malfunction
- Date Received
- January 9, 2026
- Date of Event
- December 16, 2025
- Report Date
- April 13, 2026
- Manufacturer
- BARD BRACHYTHERAPY, INC. -1424526
- Product Code
- KXK
- PMA / PMN Number
- K093663
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
H11: AS THE LOT NUMBER FOR THE DEVICE WAS NOT PROVIDED, A REVIEW OF THE DEVICE HISTORY RECORDS COULD NOT BE PERFORMED. THE RETURN OF THE SAMPLE IS PENDING. THE INVESTIGATION OF THE REPORTED EVENT IS CURRENTLY UNDERWAY. SECTION A THROUGH F ¿ THE INFORMATION PROVIDED 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.
H11: MANUFACTURING REVIEW: THE CUSTOMER DID NOT PROVIDE A SALES ORDER NUMBER FOR THIS COMPLAINT, BUT DEVICE HISTORY RECORD (DHR) REVIEW WAS PERFORMED FOR THE AFFECTED LOT NUMBER OF THE CARTRIDGE AND LINKS. NO ISSUES WERE NOTED. INVESTIGATION SUMMARY: ONE (1) STANDARD CARTRIDGE WAS RETURNED FROM THE CUSTOMER AND LABELED AS BIOHAZARDOUS. THE CARTRIDGE WAS RETURNED MISSING THE HOUSING AND CAME WITH NO LINKS INSIDE. THE SPRING AND PLUNGER WERE NO LONGER ATTACHED TO THE CARTRIDGE, BUT THE PULL TAB WAS STILL ATTACHED. THE COMPLAINT WAS FOUND CONFIRMED, AND THE ROOT CAUSE IS UNDETERMINED. LABELING REVIEW: THE CUSTOMER SALES ORDER INFORMATION WAS NOT GIVEN WITH THIS COMPLAINT; HOWEVER, THIS COMPLAINT WAS FROM A JAPAN ORDER. THE INFORMATION FOR USE (IFU) SENT WITH JAPAN ORDERS. THERE IS A CAUTION STATEMENT, WHICH STATES IN THE EVENT THE QUICKLINK LOADER OR CARTRIDGES BECOME INOPERABLE DUE TO DAMAGE OR MALFUNCTION, ANY OR ALL COMPONENTS MAY BE REMOVED FROM THE CARTRIDGES AND IMPLANTED MANUALLY. ADDITIONALLY, THERE IS A TROUBLESHOOTING SECTION FOR "CONDITION: PUSHING THE DISPENSE BUTTON DOES NOT EJECT ANY ITEMS OR PRODUCES A PARTIAL DISPENSE" WITH SEVERAL STEPS LISTED TO RESOLVE THIS ISSUE. IT ALSO HAS A NOTE THAT STATES ¿THE BUTTON MUST BE PRESSED THROUGH ITS COMPLETE RANGE OF MOTION ¿ IF THE BUTTON IS ONLY PRESSED PARTIALLY DOWN, IT WILL REMAIN IN THE MIDRANGE POSITION AND PREVENT CARRIAGE MOTION OR FURTHER DISPENSING. G3, H6 (METHOD, RESULT, CONCLUSION). SECTION A THROUGH F: THE INFORMATION PROVIDED 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.
ON (B)(6) 2025, A PATIENT UNDERWENT A BRACHYTHERAPY PROCEDURE THROUGH THE BRACHYTHERAPY LINKS & CARTRIDGES. PRIOR TO THE PROCEDURE, IT WAS REPORTED THAT THE STANDARD CARTRIDGE HAD BEEN STERILIZED IN AN UNFINISHED MOLDED STATE. THE CARTRIDGE FELL APART WHEN THE STERILIZATION PACK WAS OPENED. THERE WAS NO PATIENT CONTACT.
ON (B)(6) 2025, A PATIENT UNDERWENT A BRACHYTHERAPY PROCEDURE THROUGH THE BRACHYTHERAPY LINKS & CARTRIDGES. PRIOR TO THE PROCEDURE, IT WAS REPORTED THAT THE STANDARD CARTRIDGE HAD BEEN STERILIZED IN AN UNFINISHED MOLDED STATE. THE CARTRIDGE FELL APART WHEN THE STERILIZATION PACK WAS OPENED. THERE WAS NO PATIENT CONTACT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 79870 | I125 SEEDS IN QUICKLINK, STERILE, 13.1 MBQ | BRACHYTHERAPY LINKS & CARTRIDGES | KXK | BARD BRACHYTHERAPY, INC. -1424526 | BBKT0024 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |