BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BIOFLO

    MDR report key: 8114951 · Received November 29, 2018

    Report

    Report Number
    8114951
    Event Type
    Malfunction
    Date Received
    November 29, 2018
    Date of Event
    November 8, 2018
    Report Date
    November 9, 2018
    Manufacturer
    NAVILYST MEDICAL, INC.
    Product Code
    FOZ
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    NV
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    WHILE PLACING THE MIDLINE CATH WIRE INSERTED THROUGH THE NEEDLE, THE WIRE WAS UNABLE TO BE PULLED BACK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    955836 BIOFLO CATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS THAN 30 DAYS FOZ NAVILYST MEDICAL, INC. 46470 5384768

    Patients

    Seq Age Sex Outcome Treatment
    1 20075 DA