BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIOFLO MIDLINE CATHETER

    MDR report key: 10448120 · Received August 24, 2020

    Report

    Report Number
    MW5096223
    Event Type
    Injury
    Date Received
    August 24, 2020
    Date of Event
    August 19, 2020
    Report Date
    August 20, 2020
    Manufacturer
    ANGIODYNAMICS/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 (DUAL LUMEN) WAS ABOUT TO BE INSERTED, BUT ONE LUMEN COULD NOT BE FLUSHED SO THE CATHETER WAS SEQUESTERED. FDA SAFETY REPORT ID# (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    910966 BIOFLO MIDLINE CATHETER CATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT-TERM LESS THAN 30 DAYS FOZ ANGIODYNAMICS/NAVILYST MEDICAL INC. / ANGIODYNAMICS, INC. UPN H965460140 5601864

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Required Intervention