BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CADD MEDICATION CASSETTES

    MDR report key: 14983109 · Received July 11, 2022

    Report

    Report Number
    3012307300-2022-13248
    Event Type
    Malfunction
    Date Received
    July 11, 2022
    Date of Event
    June 9, 2022
    Report Date
    July 11, 2022
    Manufacturer
    SMITHS MEDICAL ASD, INC.
    Product Code
    FPA
    UDI-DI
    15019517191820
    PMA / PMN Number
    K040636
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    NO PRODUCT OR PHOTOGRAPHIC EVIDENCE WERE PROVIDED TO AID IN THIS INVESTIGATION. THE COMPLAINT REPORT OFFERED INSUFFICIENT DETAILS TO DETERMINE WHETHER THIS PRODUCT FUNCTIONED AS INTENDED, OR WAS USED IN A MANNER CONSISTENT WITH ITS INSTRUCTIONS FOR USE (IFU) OR FAILED TO MEET PRODUCT SPECIFICATIONS. LACKING ANY ADDITIONAL EVIDENCE, THIS COMPLAINT HAS BEEN CLOSED AS UNCONFIRMED. IF THE PRODUCT IS RETURNED, SMITHS MEDICAL WILL REOPEN THIS COMPLAINT FOR FURTHER INVESTIGATION. A MANUFACTURING DHR REVIEW WAS NOT PERFORMED BECAUSE THE RESULTS OF THE COMPLAINT INVESTIGATION DO NOT INDICATE A PROBLEM WITH THE MANUFACTURE OF THE DEVICE.

    Description of Event or Problem · 0

    (3/3 REFERENCE (B)(4) FOR RELATED COMPLAINTS) (DOCUMENTING 1/1 LEAKING AT THE SIDE PORT) PER EMAIL: NURSES ARE REPORTING LEAKING TUBING ON THE MILRINONE PATIENTS. THREE INSTANCES OF LEAKING AT THE FILTER AND ONE INSTANCE OF LEAKING FROM THE SIDE PORT OF THE TUBING. THE CADD TUBING NUMBER IS 21-7343-24 AND THE LOT# IS 4232329.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1016704 CADD MEDICATION CASSETTES SET, ADMINISTRATION, INTRAVASCULAR FPA SMITHS MEDICAL ASD, INC. 21-7343-24 15019517191820

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown