BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CADD EXTENSION SET

    MDR report key: 18103827 · Received November 8, 2023

    Report

    Report Number
    MW5147999
    Event Type
    Malfunction
    Date Received
    November 8, 2023
    Date of Event
    October 26, 2023
    Report Date
    November 6, 2023
    Manufacturer
    SMITHS MEDICAL ASD, INC.
    Product Code
    FPA
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    SMITH MEDICAL 21-7108-24 CADD EXTENSION SET 229 CM (90 IN) 2.4 ML (EPIDURAL CATHETER) HAD SEVERAL LEAKAGES AROUND THE IN-LINE FILTER AREA IN THE LABOR AND DELIVERY UNIT. 2028-03-03 LOT 4379834 NOTED SOME LABOR PATIENTS REQUIRED ADDITIONAL MEDICATIONS TO HELP WITH THEIR LABOR PAIN MORE THAN USUAL. DIFFERENT PROVIDERS NOTED EPIDURAL CATHETER LEAKAGE AROUND IN-LINE FILTER AREA ON DIFFERENT OCCASIONS IN THE LAST 2-4 WEEKS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    235800 CADD EXTENSION SET SET, ADMINISTRATION, INTRAVASCULAR FPA SMITHS MEDICAL ASD, INC. 4379834

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Other