BEUDAMED
    FDA Adverse Event Injury Summary report: N

    POWERPORT M.R.I. IMPLANTABLE PORT, CHRONOFLEX SINGLE-LUMEN, 8F

    MDR report key: 19702609 · Received July 9, 2024

    Report

    Report Number
    3006260740-2024-03567
    Event Type
    Injury
    Date Received
    July 9, 2024
    Date of Event
    June 13, 2024
    Report Date
    June 14, 2024
    Manufacturer
    C.R. BARD, INC. (BASD) -3006260740
    Product Code
    LJT
    UDI-DI
    00801741000430
    PMA / PMN Number
    K063377
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    AS THE LOT NUMBER FOR THE DEVICE WAS PROVIDED, A REVIEW OF THE DEVICE HISTORY RECORDS 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. H10: D4 (EXPIRY DATE: 12/2099) 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

    IT WAS REPORTED THROUGH LITIGATION PROCESS THAT SOMETIMES POST A PORT PLACEMENT, THE PATIENT ALLEGEDLY DEVELOPED WITH THROMBOSIS. THE CURRENT STATUS OF THE PATIENT IS UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    257248 POWERPORT M.R.I. IMPLANTABLE PORT, CHRONOFLEX SINGLE-LUMEN, 8F PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR LJT C.R. BARD, INC. (BASD) -3006260740 REBR0369 00801741000430

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention