BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SAFE-T-CARE INFUSION SET

    MDR report key: 280264 · Received May 31, 2000

    Report

    Report Number
    MW1019030
    Event Type
    Malfunction
    Date Received
    May 31, 2000
    Manufacturer
    CHILDREN'S MEDICAL VENTURES, INC.
    Product Code
    FPA
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    GA, US
    Reporter Occupation
    INVALID DATA

    Narratives

    Description of Event or Problem · 1

    SAFETY DEVICE HAD POPPED OFF OF TUBING AND ALLOWED BAG OF IVF TO DRIP FREELY INTO PT, APPROX 240 CC'S OVER A 5 HR PERIOD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SAFE-T-CARE INFUSION SET IV TUBING FPA CHILDREN'S MEDICAL VENTURES, INC. * *

    Patients

    Seq Age Sex Outcome Treatment
    1 1 DAY Other