BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CADD CASSETTE

    MDR report key: 20752651 · Received November 21, 2024

    Report

    Report Number
    3012307300-2024-13862
    Event Type
    Malfunction
    Date Received
    November 21, 2024
    Date of Event
    October 1, 2024
    Report Date
    November 21, 2024
    Manufacturer
    SMITHS MEDICAL ASD, INC.
    Product Code
    FPA
    PMA / PMN Number
    UNKNOWN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    SECTION D: A LOT NUMBER WAS PROVIDED. HOWEVER, THE LOT NUMBER DOES NOT MATCH ANY CASSETTE LOT NUMBERS IN MANUFACTURING RECORDS. NEITHER SAMPLES NOR PICTURES WERE RECEIVED FOR THE ANALYSIS OF THIS COMPLAINT. THE DEVICE HISTORY RECORD OF REPORTED LOT NUMBER 2102404 WAS REVIEWED, AND IT WAS CONFIRMED THAT NO NON-CONFORMITIES WERE REPORTED DURING PRODUCTION. THE QUALITY INSPECTION FORMS WERE REVIEWED, AND IT WAS OBSERVED THAT NO DEFECTS WERE FOUND, AND THE LOT WAS RELEASED. IF THE PRODUCT IS RETURNED, LSM WILL REOPEN THIS COMPLAINT FOR FURTHER INVESTIGATION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE LAST TWO DELIVERIES OF REMODULIN SUPPLIES HAD 1 CASSETTE WITH A BROKEN SEAL THAT LOOKED LIKE A SLICE. THERE WAS NO INTERRUPTION TO THERAPY, MISSED DOSES OR ADVERSE EVENTS REPORTED DUE TO PRODUCT ISSUE. THERE WAS A PATIENT INVOLVEMENT AND UNKNOWN PATIENT HARM/ADVERSE EVENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1777250 CADD CASSETTE SET, ADMINISTRATION, INTRAVASCULAR FPA SMITHS MEDICAL ASD, INC. 2102404

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female REMODULIN