BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SET, ADMIN, CADD, 108", SPIKE

    MDR report key: 9881026 · Received March 25, 2020

    Report

    Report Number
    3012307300-2020-02401
    Event Type
    Malfunction
    Date Received
    March 25, 2020
    Date of Event
    February 25, 2020
    Report Date
    May 12, 2020
    Manufacturer
    SMITHS MEDICAL ASD, INC.
    Product Code
    FPA
    UDI-DI
    10610586027536
    PMA / PMN Number
    K040636
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    INFORMATION WAS RECEIVED ON 04/15/2020 INDICATING LOT NUMBER. ADDITIONAL INFORMATION WAS RECEIVED ON 04/29/2020 INDICATING EVENT DATE.

    Description of Event or Problem · 1

    INFORMATION WAS RECEIVED INDICATING THAT A SMITHS MEDICAL SET, ADMIN, CADD, 108", SPIKE TUBING WAS IMPLICATED IN AN INACCURATE FLOW COMPLAINT RESULTING IN UNDER-DELIVERY OF CHEMOTHERAPY DRUGS. THERE WERE NO REPORTED ADVERSE EVENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    342370 SET, ADMIN, CADD, 108", SPIKE SET, ADMINISTRATION, INTRAVASCULAR FPA SMITHS MEDICAL ASD, INC. 21-7394-24 3840859 10610586027536

    Patients

    Seq Age Sex Outcome Treatment
    1