BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 10299739 · Received July 20, 2020

    Report

    Report Number
    3006260740-2020-02580
    Event Type
    Malfunction
    Date Received
    July 20, 2020
    Report Date
    July 20, 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 PROVIDED; THEREFORE, A LOT HISTORY REVIEW IS CURRENTLY BEING PERFORMED. THE SAMPLE WAS NOT RETURNED TO THE MANUFACTURER FOR INSPECTION/EVALUATION. THEREFORE, THE INVESTIGATION OF THE REPORTED EVENT IS INCONCLUSIVE. BASED UPON THE AVAILABLE INFORMATION, THE DEFINITIVE ROOT CAUSE FOR THIS EVENT 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 PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR ALLEGEDLY EXPERIENCED MATERIAL SEPARATION AND DEFORMATION DUE TO COMPRESS STRESS. THIS REPORT WAS RECEIVED FROM ONE SOURCE. THIS MALFUNCTION INVOLVED ONE PATIENT WITH NO PATIENT CONSEQUENCES. AGE, WEIGHT, AND GENDER WERE NOT PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    763063 POWERPORT ISP MRI 6CF INT W SP, ATT, SL PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR LJT BARD ACCESS SYSTEMS REDY1118 00801741098956

    Patients

    Seq Age Sex Outcome Treatment
    1