BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    POWERPORT ISP MRI 6CF INT W SP, ATT, SL

    MDR report key: 9602516 · Received January 17, 2020

    Report

    Report Number
    3006260740-2020-00223
    Event Type
    Malfunction
    Date Received
    January 17, 2020
    Report Date
    January 17, 2020
    Manufacturer
    BARD ACCESS SYSTEMS
    Product Code
    LJT
    UDI-DI
    00801741098956
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE LOT NUMBER FOR THE MALFUNCTION WAS NOT PROVIDED AND A LOT HISTORY REVIEW COULD NOT BE PERFORMED. THE DEVICE HAS NOT BEEN RETURNED FOR EVALUATION; THEREFORE, THE INVESTIGATION IS INCONCLUSIVE FOR THE FLUID LEAK AS NO OBJECTIVE EVIDENCE HAS BEEN PROVIDED TO CONFIRM ANY ALLEGED DEFICIENCY WITH THE DEVICE. 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 8806060 IMPLANTABLE PORT ALLEGEDLY EXPERIENCED FLUID LEAK. THIS INFORMATION WAS RECEIVED FROM ONE SOURCE. THE MALFUNCTION INVOLVED A PATIENT WITH NO KNOWN IMPACT TO THE PATIENT. THE PATIENT¿S AGE, WEIGHT, AND GENDER WERE NOT PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    64383 POWERPORT ISP MRI 6CF INT W SP, ATT, SL IMPLANTABLE PORT LJT BARD ACCESS SYSTEMS UNKNOWN 00801741098956

    Patients

    Seq Age Sex Outcome Treatment
    1