BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CADD MEDICATION CASSETTE RESERVOIRS WITH FLOW STOP

    MDR report key: 13771688 · Received March 15, 2022

    Report

    Report Number
    3012307300-2022-04580
    Event Type
    Malfunction
    Date Received
    March 15, 2022
    Date of Event
    February 14, 2022
    Report Date
    May 10, 2023
    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
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    OTHER, OTHER TEXT: THIS REMEDIATION MDR WAS GENERATED UNDER PROTOCOL (B)(4), AS A RESULT OF WARNING LETTER CMS# (B)(4). PLEASE DISREGARD THE INITIAL REPORT SUBMITTED WITH THE MFR NUMBER: 3012307300-2022-04580. THE REPORT WAS SUBMITTED IN ERROR.

    Additional Manufacturer Narrative · 0

    H6: EVENT PROBLEM AND EVALUATION CODES: UPDATED. H10: DEVICE EVALUATION: THE DEVICE WAS RETURNED FOR INVESTIGATION. A VISUAL INSPECTION AND FUNCTIONAL TEST WERE PERFORMED. PICTURE ATTACHED: ONE PICTURE WAS ATTACHED AND REVIEWED. RESULTS: PICTURE SHOW A CASSETTE PRODUCT FROM PART NUMBER 21-7302-24 AND LOT NUMBER 4163622, CASSETTE IS OUT OF ITS ORIGINAL PACKAGING. SAMPLES RECEIVED: ONE (1) SAMPLE WAS RECEIVED, SAMPLE CONSIST IN ONE (1) CASSETTE PRODUCT FROM PART NUMBER 21-7302-24. SAMPLE WAS RECEIVED IN WITH ITS ORIGINAL PACKAGING INSIDE IN A PLASTIC BAG IN UNUSED CONDITIONS. SAMPLE RECEIVED HAVE A BLUE CLIP DETACHED. FAILURE MODE IN PROCESS: IF THE BLUE CLIP COMES IS NOT PRESENT IT CAN BE EASILY NOTICED WHEN THE CLIP IS NOT PRESENT BECAUSE IT CAN?T BE ASSEMBLY AND THE LEAK TEST COULD NOT BE PERFORMED THE SPRING OCCLUSION WILL BE ACTIVATED AND THE CASSETTE WILL BE OCCLUDED. THE MOST PROBABLE ROOT CAUSE IS THAT THE BLUE CLIP WAS LOOSE AFTER THE PRODUCT LEFT SHM FACILITIES. THE CAUSE OF THE REPORTED PROBLEM COULD NOT BE DETERMINED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT CADD RESERVOIR CASSETTE, IMMEDIATELY AFTER OPENING THE PACKAGE, THE CUSTOMER NOTICED THE BLUE CLIP WAS DETACHED FROM THE CASSETTE HOUSING. NO PATIENT INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    29935 CADD MEDICATION CASSETTE RESERVOIRS WITH FLOW STOP CASSETTE FPA ST PAUL 21-7302-24 4163622 10610586027239

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Female