BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CADD CASSETTE RESERVOIRS

    MDR report key: 10248403 · Received July 8, 2020

    Report

    Report Number
    3012307300-2020-07067
    Event Type
    Malfunction
    Date Received
    July 8, 2020
    Report Date
    October 13, 2020
    Manufacturer
    SMITHS MEDICAL ASD, INC.
    Product Code
    FPA
    UDI-DI
    10610586032370
    PMA / PMN Number
    K081156
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    ONE PICTURE OF A CADD CASSETTE RESERVOIR WAS RECEIVED FOR EVALUATION. IN THE PICTURE, IT COULD BE OBSERVED THAT THERE WAS A DROP OF WATER IN THE BAG. ONE CADD CASSETTE RESERVOIR WITH PART NUMBER 21-7308-24 AND LOT NUMBER 3882466 RECEIVED IN USED CONDITION INSIDE A PLASTIC BAG WITH ITS ORIGINAL OPEN PACKAGING. THE SAMPLE WAS VISUALLY INSPECTED AT A DISTANCE OF 12? TO 16? UNDER NORMAL CONDITIONS OF ILLUMINATION; NO DAMAGES WERE DETECTED. A SYRINGE WAS USED TO INFUSE WATER INTO THE CASSETTE BAG; THERE WAS A LEAK IN THE BAG. LEAK TESTING WAS REVIEWED TO ENSURE THAT MEASURES ARE WITHIN SPECIFICATION, NO DISCREPANCIES WERE FOUND. THE REPORTED ISSUE WAS ABLE TO BE CONFIRMED. THE CAUSE OF THE ISSUE WAS UNABLE TO BE DETERMINED.

    Description of Event or Problem · 1

    INFORMATION WAS RECEIVED THAT DURING PRE-USE CHECK OF THIS SMITHS MEDICAL CADD CASSETTE RESERVOIRS, THE CUSTOMER NOTICED THE FLUID WAS LEAKING FROM THE MEDICATION BAG. NO REPORTED ADVERSE EFFECTS OR PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    711911 CADD CASSETTE RESERVOIRS SET, ADMINISTRATION, INTRAVASCULAR FPA SMITHS MEDICAL ASD, INC. 250ML, FS 12/BX 3882466 10610586032370

    Patients

    Seq Age Sex Outcome Treatment
    1