BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CADD CASSETTE RESERVOIRS - NON FLOW STOP

    MDR report key: 14312517 · Received May 6, 2022

    Report

    Report Number
    3012307300-2022-07883
    Event Type
    Malfunction
    Date Received
    May 6, 2022
    Date of Event
    January 5, 2021
    Report Date
    May 25, 2022
    Manufacturer
    ST PAUL
    Product Code
    FRN
    UDI-DI
    10610586022111
    PMA / PMN Number
    K843772
    Removal / Correction Number
    Z-0148-2022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    A DEVICE HISTORY RECORD (DHR) REVIEW WAS CONDUCTED WHICH INDICATED ALL INSPECTIONS WERE COMPLETED AND NO ISSUES WERE NOTED DURING MANUFACTURE. A PRODUCT SAMPLE WAS RECEIVED FOR EVALUATION. VISUAL AND FUNCTIONAL TESTING WERE PERFORMED. SAMPLE WAS RECEIVED WITHOUT ITS ORIGINAL PACKAGING INSIDE IN A PLASTIC BAG. SAMPLE CONSIST IN A CASSETTE PRODUCT. THE SAMPLE RECEIVED PRESENTED A MARK IN THE EXTENSION TUBE, HOWEVER THAT MARKS IN THE EXTENSION TUBE ARE CAUSED AT THE MOMENT TO ACTIVATE THE SLIDE CLAMP THIS CONDITION IS NOT VERIFY IN CASSETTE PROCESS DUE SLIDE CLAMP MUST BE DON'T ACTIVATE. THE ROOT CAUSE COULD NOT BE DETERMINED DUE COMPLAINT WAS NOT CONFIRMED, MARKS IN EXTENSION TUBE WAS GENERATED AFTER RELEASED.

    Additional Manufacturer Narrative · 0

    WHILE PERFORMING A REVIEW OF SUBMITTED MDR REPORT IT WAS DISCOVERED THAT THIS FILE WAS INADVERTENTLY ASSESSED AS REPORTABLE. NO PATIENT DEATH, SERIOUS INJURY, AND NO EVIDENCE OF A REPORTABLE PRODUCT MALFUNCTION. THE HAZARDOUS SITUATION FOR THE GIVEN COMPLAINT DEVICE WOULD NOT LIKELY CAUSE OR CONTRIBUTE TO A DEATH OR SERIOUS INJURY IF THE MALFUNCTION WERE TO RECUR. FILE CC-0100631 IS NO LONGER CONSIDERED REPORTABLE, PLEASE DISREGARD ANY MDR REPORTS ASSOCIATED WITH IT.

    Description of Event or Problem · 0

    IT WAS REPORTED WHEN FILLING THE CASSETTE, THE SLIDING CLAMP TAKES UP DIFFERENT POSITIONS AND THERE ARE NOTCHES IN THE TUBE AS A RESULT. NO PATIENT INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1099880 CADD CASSETTE RESERVOIRS - NON FLOW STOP PUMP, INFUSION FRN ST PAUL 21-7001-24 4013368 10610586022111

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown