BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AMBIT

    MDR report key: 16014925 · Received December 20, 2022

    Report

    Report Number
    16014925
    Event Type
    Malfunction
    Date Received
    December 20, 2022
    Date of Event
    October 21, 2022
    Report Date
    October 28, 2022
    Manufacturer
    SUMMIT MEDICAL PRODUCTS, INC.
    Product Code
    FRN
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    WI
    Reporter Occupation
    RISK MANAGER
    Health Professional
    N

    Narratives

    Description of Event or Problem · 0

    AMBIT PUMP TUBING "LEAKING". NEW PRODUCT OPENED. PRODUCT NUMBER IS #220140. FILTER, SPIKE, CONNECTOR TUBING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2701630 AMBIT PUMP, INFUSION FRN SUMMIT MEDICAL PRODUCTS, INC. 220140

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown