BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    POWERLINE 6 FR D/L MI W/SCUFF

    MDR report key: 9596957 · Received January 16, 2020

    Report

    Report Number
    3006260740-2020-00145
    Event Type
    Malfunction
    Date Received
    January 16, 2020
    Report Date
    July 10, 2020
    Manufacturer
    BARD ACCESS SYSTEMS
    Product Code
    LJS
    UDI-DI
    00801741036606
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    H10: THE LOT NUMBER FOR THE MALFUNCTION WAS PROVIDED AND A LOT HISTORY REVIEW WAS PERFORMED. THE DEVICE AND PHOTO WERE RETURNED FOR EVALUATION. THE INVESTIGATION CONFIRMED FOR DEFECTIVE COMPONENT AND FRACTURE. THE DEFINITIVE 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 0700615 CHRONIC CATHETER ALLEGEDLY EXPERIENCED A DEFECTIVE COMPONENT. THIS INFORMATION WAS RECEIVED FROM A SINGLE SOURCE. THE MALFUNCTION INVOLVED A PATIENT WITH NO REPORTED CONSEQUENCE. THE PATIENT¿S AGE, WEIGHT, AND SEX WERE NOT PROVIDED.

    Additional Manufacturer Narrative · 1

    THE LOT NUMBER FOR THE MALFUNCTION WAS PROVIDED AND A LOT HISTORY REVIEW WAS PERFORMED. THE DEVICE HAS BEEN RETURNED FOR EVALUATION AS WELL AS A PHOTO OF THE REPORTED MALFUNCTION; THE EVALUATION IDENTIFIED A DEFECTIVE COMPONENT. BASED UPON THE AVAILABLE INFORMATION, THE DEFINITIVE ROOT CAUSE IS UNKNOWN. 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 0700615 CHRONIC CATHETER ALLEGEDLY EXPERIENCED A DEFECTIVE COMPONENT. THIS INFORMATION WAS RECEIVED FROM A SINGLE SOURCE. THE MALFUNCTION INVOLVED A PATIENT WITH NO REPORTED CONSEQUENCE. THE PATIENT¿S AGE, WEIGHT, AND SEX WERE NOT PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    61325 POWERLINE 6 FR D/L MI W/SCUFF CHRONIC CATHETER LJS BARD ACCESS SYSTEMS 0700615 RECQ1972 00801741036606

    Patients

    Seq Age Sex Outcome Treatment
    1