BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CADD ADMINISTRATION SET

    MDR report key: 10478521 · Received September 1, 2020

    Report

    Report Number
    3012307300-2020-08915
    Event Type
    Malfunction
    Date Received
    September 1, 2020
    Date of Event
    July 30, 2020
    Report Date
    October 22, 2020
    Manufacturer
    ST PAUL
    Product Code
    FPA
    UDI-DI
    10610586025266
    PMA / PMN Number
    K933390
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    OTHER, OTHER TEXT: DEVICE EVALUATION- TWO USED SAMPLES WERE RECEIVED FOR EVALUATION. FOR ONE OF THE SAMPLES, DELAMINATION WAS SEEN AT ONE OF THE FILTER/TUBE JOINS. ONE OF THE SAMPLES WAS GIVEN FUNCTIONAL TESTING; THIS SHOWED LEAKING AT THE AIR VENT OF THE FILTER. IT WAS DETERMINED POSSIBLE THAT THE FILTER ISSUE WAS CAUSED BY USE OF AN INFUSION SOLUTION HIGH IN SURFACTANTS OR SILICONE OIL TRANSFERRING FROM A FILLING SYRINGE DURING PREPARATION. THE ISSUE WAS NOT ATTRIBUTED TO A MANUFACTURING ISSUE BUT CAUSE WAS NOT DEFINITELY ESTABLISHED.

    Additional Manufacturer Narrative · 1

    PRODUCT COMPLAINT ANALYST.

    Description of Event or Problem · 1

    INFORMATION WAS RECEIVED INDICATING THAT THERE HAVE BEEN SEVERAL INSTANCES OF BLINATUMUNAB AND ONE INSTANCE OF FLUOROURACIL LEAKING AT THE FILTER SITE OF A SMITHS MEDICAL CADD ADMINISTRATION SET TUBING. THE LOT NUMBER IS UNKNOWN, BUT POSSIBLE LOT NUMBERS ARE 3957622, 3910211, 3910210 AND 3931790. THERE WAS NO PATIENT/CLINICAL INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    943215 CADD ADMINISTRATION SET SET, ADMINISTRATION, INTRAVASCULAR FPA ST PAUL 21-7094-24 10610586025266

    Patients

    Seq Age Sex Outcome Treatment
    1