BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CADD

    MDR report key: 11558603 · Received March 23, 2021

    Report

    Report Number
    3012307300-2021-02441
    Event Type
    Malfunction
    Date Received
    March 23, 2021
    Date of Event
    February 1, 2021
    Report Date
    May 28, 2021
    Manufacturer
    ST PAUL
    Product Code
    FPA
    UDI-DI
    10610586027215
    PMA / PMN Number
    K040636
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    OTHER, OTHER TEXT: RETURNED DEVICE WAS RECEIVED FOR EVALUATION. DURING THE EVALUATION OF THE DEVICE THE CUSTOMER REPORTED CONDITION WAS CONFIRMED. PROBLEM SOURCE WAS TRACED TO MANUFACTURING. THE DEVICE HISTORY RECORD WAS REVIEWED AND SHOWED THAT THIS DEVICE MET ALL MANUFACTURING SPECIFICATION FOR PRODUCT RELEASED FOR DISTRIBUTION. NO ISSUES WERE IDENTIFIED THAT WOULD HAVE IMPACTED THIS EVENT.

    Additional Manufacturer Narrative · 1

    CUSTOMER IS NOT SURE ON THE AFFECTED LOT, BUT BELIEVES IT'S EITHER 40377749 OR 4034019.

    Description of Event or Problem · 1

    INFORMATION WAS RECEIVED REGARDING A CADD CASSETTE RESERVOIR. IT WAS REPORTED THAT IMMEDIATELY AFTER STARTING TO USE THE PRODUCT FOR THE PATIENT, THE CUSTOMER NOTICED MEDICAL FLUID WAS LEAKING FROM IT. THERE WAS NO PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    450200 CADD INTRAVASCULAR ADMINISTRATION SET FPA ST PAUL 21-7301-24 10610586027215

    Patients

    Seq Age Sex Outcome Treatment
    1