BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SET, EXTENSION, 60", M/M, 1.7 ML, ASV 50/BX

    MDR report key: 20945665 · Received December 16, 2024

    Report

    Report Number
    3012307300-2024-14960
    Event Type
    Malfunction
    Date Received
    December 16, 2024
    Date of Event
    November 14, 2024
    Report Date
    December 16, 2024
    Manufacturer
    SMITHS MEDICAL ASD, INC.
    Product Code
    FPA
    PMA / PMN Number
    K942046
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    D4: POSSIBLE LOT NUMBERS: 6022100, 6012584. H3: NEITHER SAMPLES NOR PICTURES WERE RECEIVED FOR THE ANALYSIS OF THIS COMPLAINT. THE DEVICE HISTORY RECORD OF REPORTED LOT NUMBER 6022100 AND 6012584 WERE 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. WITHOUT THE RETURN OF THE SAMPLES A COMPREHENSIVE FAILURE INVESTIGATION CANNOT BE PERFORMED, AND A PROBABLE CAUSE CANNOT BE DETERMINED. IF THE PRODUCT IS RETURNED, THE COMPLAINT WILL BE REOPENED FOR FURTHER INVESTIGATION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE TUBING HAD BECOME SEPARATED WHILE THE PATIENT WAS SLEEPING. PER REPORTER, THE PATIENT WAS CLEANED UP AND CLOSED THE CLAMP CLOSEST TO THE PORT. CHEMO SPILL INSTRUCTIONS WERE REVIEWED, AND PATIENT WAS REDIRECTED TO THE CLINIC. NO PATIENT HARM/ADVERSE EVENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2355439 SET, EXTENSION, 60", M/M, 1.7 ML, ASV 50/BX SET, ADMINISTRATION, INTRAVASCULAR FPA SMITHS MEDICAL ASD, INC. UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown