BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    QUICKLINK¿ LOADER

    MDR report key: 7033070 · Received November 15, 2017

    Report

    Report Number
    1018233-2017-05907
    Event Type
    Malfunction
    Date Received
    November 15, 2017
    Report Date
    February 15, 2018
    Manufacturer
    BARD BRACHYTHERAPY, INC. -1424526
    Product Code
    IWJ
    UDI-DI
    00801741079238
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE REPORTED EVENT WAS CONFIRMED. INITIAL OBSERVATION NOTED THAT THE LOADER WAS RECEIVED WITH A BENT STYLET INSTALLED. ADDITIONALLY, THE BLADE ARM ASSEMBLY WAS NOT IN PROPER ALIGNMENT. IN THIS CONDITION, DEPRESSING THE DISPENSE BUTTON WOULD NOT PUSH A SEED OR LINK COMPLETELY INTO THE SLOT COVER. THIS CONDITION WOULD CREATE A JAM IF THE CARRIAGE WAS MOVED. THE ROOT CAUSE WAS THE PIN THAT HOLDS THE BLADE ARM IN PLACE WAS BROKEN. 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: "PUSHING THE DISPENSE BUTTON DOES NOT EJECT ANY ITEMS OR PRODUCES A PARTIAL DISPENSE." (B)(4).

    Additional Manufacturer Narrative · 1

    THE REPORTED EVENT WAS CONFIRMED; HOWEVER, THE CAUSE IN UNKNOWN. INITIAL OBSERVATION NOTED THAT THE LOADER WAS RECEIVED WITH A BENT STYLET INSTALLED. ADDITIONALLY, THE BLADE ARM ASSEMBLY WAS NOT IN PROPER ALIGNMENT. IN THIS CONDITION, DEPRESSING THE DISPENSE BUTTON WOULD NOT PUSH A SEED OR LINK COMPLETELY INTO THE SLOT COVER. THIS CONDITION WOULD CREATE A JAM IF THE CARRIAGE WAS MOVED. THE ROOT CAUSE WAS PIN THAT HOLDS THE BLADE ARM IN PLACE WAS BROKEN. 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: "PUSHING THE DISPENSE BUTTON DOES NOT EJECT ANY ITEMS OR PRODUCES A PARTIAL DISPENSE." (B)(4).

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION IS STILL IN PROGRESS. ONCE THE INVESTIGATION IS COMPLETE A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DEVICE WAS NOT WORKING CORRECTLY AS THE GRAINS WERE STUCK INSIDE OF THE DEVICE. PER FOLLOW UP, THE ISSUE WAS FOUND DURING THE PROCEDURE AND THE PROCEDURE WAS STOPPED AND RESCHEDULED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DEVICE WAS NOT WORKING CORRECTLY AS THE GRAINS WERE STUCK INSIDE OF THE DEVICE. PER FOLLOW UP, THE ISSUE WAS FOUND DURING THE PROCEDURE AND THE PROCEDURE WAS STOPPED AND RESCHEDULED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DEVICE WAS NOT WORKING CORRECTLY AS THE GRAINS WERE STUCK INSIDE OF THE DEVICE. PER FOLLOW UP, THE ISSUE WAS FOUND DURING THE PROCEDURE AND THE PROCEDURE WAS STOPPED AND RESCHEDULED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    814594 QUICKLINK¿ LOADER QUICKLINK LOADER IWJ BARD BRACHYTHERAPY, INC. -1424526 NA 00801741079238

    Patients

    Seq Age Sex Outcome Treatment
    1