BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BIOFLO MIDLINE CATHETER

    MDR report key: 10257324 · Received July 9, 2020

    Report

    Report Number
    MW5095460
    Event Type
    Malfunction
    Date Received
    July 9, 2020
    Date of Event
    July 7, 2020
    Report Date
    July 7, 2020
    Manufacturer
    NAVILYST MEDICAL INC / ANGIODYNAMICS, INC.
    Product Code
    FOZ
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    MIDLINE CATHETER PLACED (B)(6) 2020, FAILED (B)(6) 2020. UNABLE TO FLUSH EVEN FOLLOWING REMOVAL. PATIENT HAD LINE PLACED FOR CEFTRIAXONE INFUSIONS. FDA SAFETY REPORT ID # (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    719203 BIOFLO MIDLINE CATHETER CATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT-TERM LESS THAN 30 DAYS FOZ NAVILYST MEDICAL INC / ANGIODYNAMICS, INC. REF 46-012 5496934

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Other