BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 6713801 · Received July 14, 2017

    Report

    Report Number
    3006260740-2017-01045
    Event Type
    Malfunction
    Date Received
    July 14, 2017
    Date of Event
    January 14, 2016
    Report Date
    July 14, 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CATHETER COULD NOT BE CONNECTED TO THE CATHETER CONNECTOR AND THE CLICKING (LOCKING) SOUND WAS NOT HEARD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    493808 GRO NXT W/STRIPED CATH 4F SL BASIC JAPAN HANG PERCUTANEOUS, IMPLANTED, LONG-TERM INTRAVASCULAR CATHETER LJS BARD ACCESS SYSTEMS UNK

    Patients

    Seq Age Sex Outcome Treatment
    1