BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CADD

    MDR report key: 10183999 · Received June 23, 2020

    Report

    Report Number
    3012307300-2020-06175
    Event Type
    Malfunction
    Date Received
    June 23, 2020
    Date of Event
    May 1, 2020
    Report Date
    August 24, 2020
    Manufacturer
    ST PAUL
    Product Code
    FPA
    UDI-DI
    10610586027239
    PMA / PMN Number
    K040636
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    H3: ONE PICTURE OF A CADD CASSETTE RESERVOIR WAS RECEIVED AND REVIEWED. THE PICTURE SHOWED A CUT IN THE TOP PART OF THE ASSEMBLY (AY) BAG. TWO CADD CASSETTE RESERVOIR FROM P/N 21-7302-24 L/N 3900377 WERE RECEIVED IN USED CONDITIONS WITH THEIR ORIGINAL PACKAGING OPEN INSIDE IN A PLASTIC BAG. THE SAMPLES WERE VISUALLY INSPECTED, AT A DISTANCE OF 12? TO 24? AND NORMAL CONDITIONS OF ILLUMINATION. A CUT WAS DETECTED IN THE NECK OF THE AY BAG. A SYRINGE WAS USED TO INFUSE WATER INTO THE AY BAG. A LEAK WAS DETECTED IN THE NECK OF THE AY BAG. RELEVANT DOCUMENTS WERE REVIEWED AND DEEMED ADEQUATE AND CORRECT WITH RESPECT TO TESTING AND INSPECTION ACTIVITIES. THE REPORTED LEAKING ISSUE WAS ABLE TO BE CONFIRMED. THE MOST PROBABLE CAUSE IS, THAT DURING LEAK TEST OPERATION CASSETTES THAT FAILED (LEAK TEST), WERE NOT PROPERLY SEGREGATED.

    Description of Event or Problem · 1

    INFORMATION RECEIVED A SMITHS MEDICAL CADD CASSETTE RESERVOIRS - FLOW STOP NOTICED FLUID WAS LEAKING FROM THE PRODUCT. THIS WAS DISCOVERED DURING PRECHECK AND NO PATIENT INJURY OCCURRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    647201 CADD CASSETTE FLOW STOP FPA ST PAUL 21-7302-24 3900377 10610586027239

    Patients

    Seq Age Sex Outcome Treatment
    1