BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EPUMP 1000ML SAFETY SCREW SPIK

    MDR report key: 8824100 · Received July 24, 2019

    Report

    Report Number
    1282497-2019-08584
    Event Type
    Malfunction
    Date Received
    July 24, 2019
    Report Date
    July 24, 2019
    Manufacturer
    COVIDIEN
    Product Code
    LZH
    UDI-DI
    10884521155817
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INCIDENT SAMPLE HAS BEEN REQUESTED BUT TO DATE HAS NOT BEEN RECEIVED FOR EVALUATION. IF THE SAMPLE IS RECEIVED, OR IF ADDITIONAL INFORMATION PERTINENT TO THE INCIDENT IS OBTAINED A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTS THE SPIKE SET IS LEAKING. THERE WAS NO HARM TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    618393 EPUMP 1000ML SAFETY SCREW SPIK PUMP, INFUSION, ENTERAL LZH COVIDIEN 775100 190250078 10884521155817

    Patients

    Seq Age Sex Outcome Treatment
    1