BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CADD MEDICATION CASSETTE RESERVOIRS

    MDR report key: 10373603 · Received August 6, 2020

    Report

    Report Number
    3012307300-2020-07886
    Event Type
    Malfunction
    Date Received
    August 6, 2020
    Date of Event
    May 4, 2020
    Report Date
    October 19, 2020
    Manufacturer
    ST PAUL
    Product Code
    FPA
    UDI-DI
    10610586027215
    PMA / PMN Number
    K040636
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    OTHER, OTHER TEXT: H3: ONE PICTURE OF A CADD CASSETTE RESERVOIR WAS RECEIVED FOR EVALUATION AND NO DISCREPANCIES WERE OBSERVED. ONE CADD CASSETTE RESERVOIR FROM PART NUMBER 21-7301-24 LOT NUMBER 3894452 WAS 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. IT WAS OBSERVED THAT THE TUBE WAS CUT FROM THE BAG. LEAK TESTING WAS REVIEWED TO ENSURE THAT MEASURES ARE WITHIN SPECIFICATION, NO DISCREPANCIES WERE FOUND. THE MOST LIKELY CAUSE OF THE ISSUE IS THAT THE TUBE WAS DAMAGED AFTER IT LEFT THE MANUFACTURING FACILITY DUE TO THE PRODUCT'S 100% LEAK TESTING.

    Description of Event or Problem · 1

    INFORMATION WAS RECEIVED INDICATING THAT DURING FILLING OF A SMITHS MEDICAL CADD MEDICATION CASSETTE RESERVOIR, FLUID WAS OBSERVED TO BE LEAKING. IT WAS REPORTED THAT THE LEAKING WAS WITHIN THE CASSETTE HOUSING. THERE WERE NO REPORTED ADVERSE PATIENT EFFECTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    839651 CADD MEDICATION CASSETTE RESERVOIRS SET, ADMINISTRATION, INTRAVASCULAR FPA ST PAUL 21-7301-24 3894452 10610586027215

    Patients

    Seq Age Sex Outcome Treatment
    1