BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD GRAVITY SET

    MDR report key: 18375804 · Received December 21, 2023

    Report

    Report Number
    9616066-2023-02429
    Event Type
    Malfunction
    Date Received
    December 21, 2023
    Date of Event
    December 11, 2023
    Report Date
    December 12, 2023
    Manufacturer
    SISTEMAS MEDICOS ALARIS S.A. DE C.V.
    Product Code
    FPA
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H.3. IF A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS COMPLETED, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD BD GRAVITY SET WAS KINKED. THE FOLLOWING INFORMATION WAS RECEIVED BY THE INITIAL REPORTER WITH THE VERBATIM: IT WAS REPORTED THAT IN APRIL OF 2023 BD PRIMARY GRAVITY SETS THERE WERE COUPLE OF INCIDENCE AS WELL AS KINKING OF TUBE. EMAIL VERBATIM: ¿HI BDSURVEY THANK YOU FOR THE MAIL SORRY FOR THE LATE REPLY AS PER YOUR QUERY .. I ENCOUNTERED THE PROBLEM OF LEAKING AT BWH BIRMINGHAM AND THERE WERE COUPLE OF INCIDENCE AS WELL AS KINKING OF TUBE IN APRIL L2023 I REPORTED IT TO FLOOR MANAGER AND I THINK SHE SAID THAT SHE WILL REPORT IT TO SUPPLIER I DON¿T KNOW WHAT HAPPENS LATER DR (B)(6)¿.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2034094 BD GRAVITY SET INTRAVASCULAR ADMINISTRATION SET FPA SISTEMAS MEDICOS ALARIS S.A. DE C.V. UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown