BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BARD® QUICKLINK¿ CARTRIDGES WITH BRACHYSOURCE® I-125 SEEDS

    MDR report key: 7155458 · Received December 29, 2017

    Report

    Report Number
    1018233-2017-06520
    Event Type
    Malfunction
    Date Received
    December 29, 2017
    Report Date
    February 1, 2018
    Manufacturer
    BARD BRACHYTHERAPY, INC. -1424526
    Product Code
    KXK
    UDI-DI
    00801741078378
    PMA / PMN Number
    K093663
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 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.

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS NOT RETURNED FOR EVALUATION. THE LOT NUMBER IS UNKNOWN; THEREFORE, THE DEVICE HISTORY RECORD COULD NOT BE REVIEWED. THE INSTRUCTIONS FOR USE STATES THE FOLLOWING: "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. PUSHING THE DISPENSE BUTTON DOES NOT EJECT ANY ITEMS OR PRODUCES A PARTIAL DISPENSE." (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE SEEDS WOULD NOT COME OUT OF OUR CALIBRATION CARTRIDGE NO MATTER HOW MANY TIMES IT WAS RELOADED, RE-ALIGNED, PUSHED DOWN ON IT ETC, ETC NOTHING HAPPENED. THERE APPEARED TO BE SOME SORT OF MISALIGNMENT AS THE ¿EXPEL¿ BUTTON WAS JUST SOLID AND WOULDN¿T DEPRESS PROPERLY. ALSO, ON A SECOND CARTRIDGE A SEED FELL THROUGH THE LOADER AND ONTO THE BASEPLATE, BUT WE HAVE HAD THAT ON ONE OTHER PREVIOUS OCCASION. IT JUST APPEARED TO FALL OUT IE. "I DIDN¿T TRY AND LOAD IT INTO A SOURCE TRAIN AND IT JUST DIDN¿T APPEAR IN THE SOURCE TRAIN WINDOW REQUIRING ME TO HAVE A SECOND ATTEMPT OF DEPRESSING THE ¿EXPEL¿ BUTTON." ALL SOURCE TRAINS MADE UP OK FROM THAT CARTRIDGE BUT IT WAS JUST AT THE END OF THE CARTRIDGE THAT A SEED WAS ¿MISSING¿ IE. "I HAD 1 LESS SEED IN THE CARTRIDGE THAN I WAS EXPECTING NAMELY THE ONE THAT HAD FALLEN THROUGH." THE PATIENT DID NOT RECEIVED ALL SEEDS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE SEEDS WOULD NOT COME OUT OF OUR CALIBRATION CARTRIDGE NO MATTER HOW MANY TIMES IT WAS RELOADED, RE-ALIGNED, PUSHED DOWN ON IT ETC ETC NOTHING HAPPENED. THERE APPEARED TO BE SOME SORT OF MISALIGNMENT AS THE ¿EXPEL¿ BUTTON WAS JUST SOLID AND WOULDN¿T DEPRESS PROPERLY. ALSO, ON A SECOND CARTRIDGE A SEED FELL THROUGH THE LOADER AND ONTO THE BASEPLATE, BUT WE HAVE HAD THAT ON ONE OTHER PREVIOUS OCCASION. IT JUST APPEARED TO FALL OUT IE. "I DIDN¿T TRY AND LOAD IT INTO A SOURCE TRAIN AND IT JUST DIDN¿T APPEAR IN THE SOURCE TRAIN WINDOW REQUIRING ME TO HAVE A SECOND ATTEMPT OF DEPRESSING THE ¿EXPEL¿ BUTTON." ALL SOURCE TRAINS MADE UP OK FROM THAT CARTRIDGE BUT IT WAS JUST AT THE END OF THE CARTRIDGE THAT A SEED WAS ¿MISSING¿ IE. "I HAD 1 LESS SEED IN THE CARTRIDGE THAN I WAS EXPECTING NAMELY THE ONE THAT HAD FALLEN THROUGH." THE PATIENT DID NOT RECEIVED ALL SEEDS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    935198 BARD® QUICKLINK¿ CARTRIDGES WITH BRACHYSOURCE® I-125 SEEDS SEEDS KXK BARD BRACHYTHERAPY, INC. -1424526 1251QCL UNK 00801741078378

    Patients

    Seq Age Sex Outcome Treatment
    1