BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CADD

    MDR report key: 12863944 · Received November 23, 2021

    Report

    Report Number
    3012307300-2021-11762
    Event Type
    Malfunction
    Date Received
    November 23, 2021
    Date of Event
    October 14, 2021
    Report Date
    November 23, 2021
    Manufacturer
    SMITHS MEDICAL ASD, INC.
    Product Code
    FPA
    UDI-DI
    15019517191714
    PMA / PMN Number
    K031361
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    INFORMATION WAS RECEIVED REGARDING A CADD CASSETTE RESERVOIR. IT WAS REPORTED THAT TUBING WAS LEAKING AT THE FILTER SITE. PATIENT TOSSED THE PACKAGE. THE LOT NUMBERS FROM THE REMAINING SUPPLIES ARE 4170256 AND 4143042. IT IS UNKNOWN IF THERE WAS NO PATIENT, OR CLINICIAN INJURY ASSOCIATED WITH THESE OCCURRENCES. NO FURTHER DETAILS PROVIDED AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1758511 CADD INTRAVASCULAR ADMINISTRATION SET FPA SMITHS MEDICAL ASD, INC. 21-7345-24 15019517191714

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown