BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CADD

    MDR report key: 11721690 · Received April 24, 2021

    Report

    Report Number
    3012307300-2021-03450
    Event Type
    Injury
    Date Received
    April 24, 2021
    Report Date
    June 14, 2023
    Manufacturer
    ST PAUL
    Product Code
    FPA
    UDI-DI
    10610586027536
    PMA / PMN Number
    K040636
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    OTHER, OTHER TEXT: A PICTURE OF THE DEVICE WAS RECEIVED FOR EVALUATION. DURING THE EVALUATION THE CUSTOMER REPORTED CONDITION WAS NOT CONFIRMED. PER PICTURE ATTACHED, NO "LEAKAGE" CONDITION CAN BE OBSERVED. IT IS UNABLE TO CONFIRM THE FAILURE MODE REPORTED. NO FAULT FOUND. 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.

    Description of Event or Problem · 1

    INFORMATION WAS RECEIVED INDICATING THAT DURING USE OF THIS SMITHS MEDICAL CADD ADMINISTRATION SETS, THE PATIENT EXPERIENCED LEAKING FROM THE INLINE FILTER. IT WAS REPORTED THAT LEAKS OCCURRED FROM THE DIMPLE IN THE INLINE FILTER ACCORDING TO THE FATHER AND THE NURSES. BLINCYTO WAS THE DRUG BEING INFUSED USING A 48-HOUR BAG AND THE RATE WAS 5 ML/HOUR. NO PATIENT INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    617700 CADD SET, ADMINISTRATION, INTRAVASCULAR FPA ST PAUL 21-7394-24 3939040 10610586027536

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other