BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    POWERLINE 5 FR S/L MI W/SCUFF

    MDR report key: 9596523 · Received January 16, 2020

    Report

    Report Number
    3006260740-2020-00128
    Event Type
    Malfunction
    Date Received
    January 16, 2020
    Report Date
    April 3, 2020
    Manufacturer
    BARD ACCESS SYSTEMS
    Product Code
    LJS
    UDI-DI
    00801741036583
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    H10. FOR THE REPORTED MALFUNCTION, A LOT NUMBER WAS PROVIDED, AND A LOT HISTORY REVIEW WAS PERFORMED. THE SAMPLE WAS RETURNED FOR EVALUATION. THE INVESTIGATION IDENTIFIED A LEAK. THE ROOT CAUSE COULD NOT BE DETERMINED. THE DEVICE IS LABELED FOR SINGLE USE. H11: SECTION A THROUGH F - THE INFORMATION PROVIDED BY BD 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 BD.

    Description of Event or Problem · 0

    THIS REPORT SUMMARIZES ONE MALFUNCTION. A REVIEW OF THE REPORTED INFORMATION INDICATED THAT MODEL 0700515 CHRONIC CATHETER ALLEGEDLY EXPERIENCED A FLUID LEAK. THIS REPORT WAS RECEIVED FROM A SINGLE SOURCE. THIS MALFUNCTION INVOLVED A PATIENT WITH NO PATIENT CONSEQUENCES. THE WEIGHT OF THE 8 YEAR OLD MALE PATIENT WAS NOT PROVIDED.

    Additional Manufacturer Narrative · 1

    FOR THE REPORTED MALFUNCTION, A LOT NUMBER WAS PROVIDED, AND A LOT HISTORY REVIEW WAS PERFORMED. THE SAMPLE WAS RETURNED FOR EVALUATION. THE COMPANY IS STILL INVESTIGATING THE ISSUE AT THIS TIME. THE DEVICE IS LABELED FOR SINGLE USE.

    Description of Event or Problem · 1

    THIS REPORT SUMMARIZES ONE MALFUNCTION. A REVIEW OF THE REPORTED INFORMATION INDICATED THAT MODEL 0700515 CHRONIC CATHETER ALLEGEDLY EXPERIENCED A FLUID LEAK. THIS REPORT WAS RECEIVED FROM A SINGLE SOURCE. THIS MALFUNCTION INVOLVED A PATIENT WITH NO PATIENT CONSEQUENCES. THE WEIGHT OF THE (B)(6) YEAR OLD MALE PATIENT WAS NOT PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    59651 POWERLINE 5 FR S/L MI W/SCUFF CHRONIC CATHETER LJS BARD ACCESS SYSTEMS 0700515 REDU2549 00801741036583

    Patients

    Seq Age Sex Outcome Treatment
    1