BEUDAMED
    FDA Adverse Event Injury Summary report: N

    POWERPORTDUO MRI BUMPLESS 9.5FR CF, W/SUTURE PLUGS

    MDR report key: 8471713 · Received April 1, 2019

    Report

    Report Number
    3006260740-2019-00749
    Event Type
    Injury
    Date Received
    April 1, 2019
    Report Date
    April 1, 2019
    Manufacturer
    BARD ACCESS SYSTEMS
    Product Code
    LJT
    UDI-DI
    00801741027406
    PMA / PMN Number
    K090512
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    AS THE LOT NUMBER FOR THE DEVICE WAS PROVIDED, A MANUFACTURING REVIEW WILL BE 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 INSTRUCTIONS FOR USE (IFU) IS ADEQUATE FOR THE REPORTED DEVICE/PATIENT CODE(S) AND PROVIDES GENERAL INSTRUCTIONS FOR USE, AS WELL AS WARNINGS, PRECAUTIONS AND POTENTIAL COMPLICATIONS ASSOCIATED WITH THE DEVICE. UPON RECEIPT OF NEW OR ADDITIONAL INFORMATION, A FOLLOW-UP REPORT WILL BE SUBMITTED AS APPLICABLE. (EXPIRATION DATE 01/2020).

    Description of Event or Problem · 1

    IT WAS REPORTED APPROXIMATELY TWO WEEKS POST PORT PLACEMENT, THE PATIENT DEVELOPED A FEVER AND BLOOD CULTURE RESULTS DETECTED AN INFECTED PORT. IT WAS FURTHER REPORTED THAT THE PATIENT IS SCHEDULED FOR A NEW PORT PLACEMENT. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    264902 POWERPORTDUO MRI BUMPLESS 9.5FR CF, W/SUTURE PLUGS IMPLANTED PORT LJT BARD ACCESS SYSTEMS 5829502 RECW0043 00801741027406

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention