BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    POWERPORT MRI ISP, 8 FR CHRONOFLEX, SUTURE PLUG, ATTACHABLE, SL

    MDR report key: 8805725 · Received July 18, 2019

    Report

    Report Number
    3006260740-2019-02057
    Event Type
    Malfunction
    Date Received
    July 18, 2019
    Report Date
    July 18, 2019
    Manufacturer
    BARD PERIPHERAL VASCULAR, INC.
    Product Code
    LJT
    UDI-DI
    00801741027031
    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 AND A LOT HISTORY REVIEW WAS PERFORMED. THE DEVICE HAS BEEN RETURNED FOR EVALUATION; THE EVALUATION IDENTIFIED THE CATHETER WAS DETACHED FROM THE PORT. 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 1808060 PORT & CATHETER ALLEGEDLY EXPERIENCED DETACHMENT OF DEVICE OR DEVICE COMPONENT. THIS INFORMATION WAS RECEIVED FROM A SINGLE SOURCE. THE ALLEGED MALFUNCTION INVOLVED A PATIENT WITH NO KNOWN IMPACT TO THE PATIENT. THE PATIENT WAS REPORTED TO BE (B)(6), WEIGHT AND GENDER WERE NOT PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    598687 POWERPORT MRI ISP, 8 FR CHRONOFLEX, SUTURE PLUG, ATTACHABLE, SL PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR LJT BARD PERIPHERAL VASCULAR, INC. 1808060 REZJ0294 00801741027031

    Patients

    Seq Age Sex Outcome Treatment
    1