BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    POWERLINE 5 FR S/S MI W/SCUFF

    MDR report key: 9969001 · Received April 16, 2020

    Report

    Report Number
    3006260740-2020-01342
    Event Type
    Malfunction
    Date Received
    April 16, 2020
    Report Date
    June 25, 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: THE LOT NUMBER FOR THE MALFUNCTION WAS PROVIDED AND A LOT HISTORY REVIEW WAS PERFORMED. THE DEVICE WAS NOT RETURNED FOR EVALUATION; HOWEVER A VIDEO AND THE PHOTO HAS BEEN RECEIVED FOR EVALUATION. THE INVESTIGATION CONFIRMED FOR MATERIAL SEPARATION AND FLUID LEAK. A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED. THE DEVICE IS LABELED FOR SINGLE USE. H10: G4 H11: G1,H6(METHOD, RESULT & CONCLUSION) 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 ALLEGEDLY EXPERIENCED MATERIAL SEPARATION AND FLUID LEAK. THIS INFORMATION WAS RECEIVED FROM ONE SOURCE. THIS MALFUNCTION INVOLVED ONE PATIENT WITH NO CONSEQUENCES. THE WEIGHT OF 14 MONTHS OLD FEMALE PATIENT IS 8 KGS.

    Additional Manufacturer Narrative · 1

    THE LOT NUMBER FOR THE MALFUNCTION WAS PROVIDED AND A LOT HISTORY REVIEW WILL BE PERFORMED. THE DEVICE FOR THIS MALFUNCTION HAS NOT BEEN RETURNED TO THE MANUFACTURER FOR EVALUATION, HOWEVER, A VIDEO AND THE PHOTO HAS BEEN PROVIDED. THE INVESTIGATION OF THE REPORTED MALFUNCTION IS CURRENTLY UNDERWAY. 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 ALLEGEDLY EXPERIENCED MATERIAL SEPARATION AND FLUID LEAK. THIS INFORMATION WAS RECEIVED FROM ONE SOURCE. THIS MALFUNCTION INVOLVED ONE PATIENT WITH NO CONSEQUENCES. THE WEIGHT OF (B)(6) OLD FEMALE PATIENT IS (B)(6) KGS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    429798 POWERLINE 5 FR S/S MI W/SCUFF CHRONIC CATHETER LJS BARD ACCESS SYSTEMS 0700515 REDT0389 00801741036583

    Patients

    Seq Age Sex Outcome Treatment
    1