BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    1.9FX50CM VASCU-PICC

    MDR report key: 2193097 · Received July 22, 2011

    Report

    Report Number
    2518902-2011-00076
    Event Type
    Malfunction
    Date Received
    July 22, 2011
    Report Date
    July 20, 2011
    Manufacturer
    MEDCOMP
    Product Code
    LJS
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    NO INFORMATION

    Narratives

    Additional Manufacturer Narrative · 1

    AN INVESTIGATION HAS BEEN INITIATED. WE ARE CURRENTLY WAITING FOR ADD'L INFO ABOUT THE EVENT AND FOR THE RETURN OF THE DEVICE SAMPLE FOR EVAL. WHEN THE INVESTIGATION IS COMPLETE, A FINAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THE DEVICE BROKE AT CATHETER HUB JUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 1.9FX50CM VASCU-PICC INFUSION CATHETER-PICC LJS MEDCOMP MR17011101 NI

    Patients

    Seq Age Sex Outcome Treatment
    1 NI Required Intervention