BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VELOCITY DELIVERY MICROCATHETER

    MDR report key: 14931118 · Received July 6, 2022

    Report

    Report Number
    14931118
    Event Type
    Malfunction
    Date Received
    July 6, 2022
    Date of Event
    June 21, 2022
    Report Date
    June 27, 2022
    Manufacturer
    PENUMBRA, INC.
    Product Code
    DQY
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CT
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    MICROCATHETER WAS NOTED TO BE KINKED WHEN STAFF REMOVED FROM PACKAGE FOR PREPARATION. ITEM WAS DISCARDED AND A DIFFERENT CATHETER WAS USED. PENUMBRA VELOCITY MICROCATHETER VEL160STR, LOT# F113030.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1620257 VELOCITY DELIVERY MICROCATHETER CATHETER, PERCUTANEOUS DQY PENUMBRA, INC. VEL160STR F113030

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other