BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BIOFLO POWER 3 FR SINGLE LUMEN POWER PICC

    MDR report key: 6803444 · Received August 18, 2017

    Report

    Report Number
    6803444
    Event Type
    Malfunction
    Date Received
    August 18, 2017
    Date of Event
    July 22, 2017
    Report Date
    August 3, 2017
    Manufacturer
    NAVILYST MEDICAL, INC. (ANGIODYNAMICS)
    Product Code
    LJS
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT WAS NOTED THAT THE PERIPHERALLY INSERTED CENTRAL CATHETER (PICC) CRACKED CLOSE TO THE HUB, CAUSING THE FLUIDS THAT WERE RUNNING TO LEAK OUT. THIS PICC WAS ORIGINALLY PLACED WEEKS PRIOR AND THE PATIENT RECEIVED ANTIBIOTICS AT HOME. THE PATIENT WAS READMITTED TO THE HOSPITAL RECENTLY. THIS PICC HAD BEEN USED SINCE THE SECOND ADMISSION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    583760 BIOFLO POWER 3 FR SINGLE LUMEN POWER PICC CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 DAYS LJS NAVILYST MEDICAL, INC. (ANGIODYNAMICS) 5172214

    Patients

    Seq Age Sex Outcome Treatment
    1 4 YR LONG-TERM ANTIBIOTICS| NO