BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARROW

    MDR report key: 8944487 · Received August 29, 2019

    Report

    Report Number
    8944487
    Event Type
    Malfunction
    Date Received
    August 29, 2019
    Date of Event
    June 14, 2019
    Report Date
    July 25, 2019
    Manufacturer
    TELEFLEX MEDICAL
    Product Code
    FOZ
    UDI-DI
    30801902117275
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    TIP OF CATHETER IS GETTING STRIPPED. POTENTIAL FOR VASCULAR DAMAGE. 8.5 FRENCH, 20 CM., 0.032 INCH DIAMETER SPRING WIRE GUIDE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    739214 ARROW CATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT-TERM LESS THAN 30 DAYS FOZ TELEFLEX MEDICAL IPN036455 13F19C0497 30801902117275

    Patients

    Seq Age Sex Outcome Treatment
    1