BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GRO NXT W/STRIPED CATH 4F SL BASIC JPN HANG

    MDR report key: 6719917 · Received July 17, 2017

    Report

    Report Number
    3006260740-2017-01056
    Event Type
    Malfunction
    Date Received
    July 17, 2017
    Date of Event
    November 17, 2015
    Report Date
    July 17, 2017
    Manufacturer
    BARD ACCESS SYSTEMS
    Product Code
    LJS
    PMA / PMN Number
    K034020
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE INFORMATION PROVIDED BY BARD 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 BARD. THE DEVICE HAS NOT BEEN RETURNED TO THE MANUFACTURER FOR EVALUATION, AS THE DEVICE WAS DISCARDED AT MEDICON DUE TO THE EXPIRE OF STOCK PERIOD AFTER VISUAL INSPECTION. A LOT HISTORY REVIEW (LHR) REVIEW IS NOT POSSIBLE, AS NO MANUFACTURING LOT NUMBER HAS BEEN PROVIDED BY THE COMPLAINANT. DISCARDED AT MEDICON DUE TO THE EXPIRE OF STOCK PERIOD AFTER VISUAL INSPECTION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT MEDICINE LEAK INCLUDING BLOOD FROM THE CATHETER OUTSIDE OF THE BODY WAS FOUND BY THE PATIENT DURING CHEMOTHERAPY. THE CATHETER WAS IMPLANTED FOR CHEMOTHERAPY AROUND THE LEFT FOREARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    500108 GRO NXT W/STRIPED CATH 4F SL BASIC JPN HANG PERCUTANEOUS, IMPLANTED, LONG-TERM INTRAVASCULAR CATHETER LJS BARD ACCESS SYSTEMS UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR