BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DELTEC GRIPPER PLUS 20G/1IN

    MDR report key: 22070354 · Received May 22, 2025

    Report

    Report Number
    MW5170718
    Event Type
    Malfunction
    Date Received
    May 22, 2025
    Date of Event
    May 13, 2025
    Report Date
    May 19, 2025
    Manufacturer
    ICU MEDICAL, INC.
    Product Code
    FPA
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    IN, US
    Reporter Occupation
    RISK MANAGER
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    HUBER NEEDLE PS#: 19119, LOT NUMBER: 6023345, EXPIRES: 06/07/2029 (DELTEC GRIPPER PLUS 20G/1IN). FLUID/MED COMES OUT OF THE COLLAR OF THE PORT CLOSEST TO THE ACCESS NEEDLE. I WAS ABLE TO SLOW DOWN THE INFUSION TO PREVENT IT FROM LEAKING. THE ONLY ISSUE WITH THE PATIENT WAS THE LONGER TIME IN THE CHAIR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    818762 DELTEC GRIPPER PLUS 20G/1IN SET, ADMINISTRATION, INTRAVASCULAR FPA ICU MEDICAL, INC. PS#19119 6023345

    Patients

    Seq Age Sex Outcome Treatment
    1 37 YR Female