BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD ALARIS SYRINGE MODULE SYRINGE ADMINISTRATION SET

    MDR report key: 18298657 · Received December 10, 2023

    Report

    Report Number
    9616066-2023-02379
    Event Type
    Malfunction
    Date Received
    December 10, 2023
    Date of Event
    November 15, 2023
    Report Date
    December 8, 2023
    Manufacturer
    SISTEMAS MEDICOS ALARIS S.A. DE C.V.
    Product Code
    FPA
    UDI-DI
    10885403233906
    PMA / PMN Number
    K811885
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    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 ALARIS SYRINGE MODULE SYRINGE ADMINISTRATION SET WAS DAMAGED. THE FOLLOWING INFORMATION WAS RECEIVED BY THE INITIAL REPORTER WITH THE VERBATIM: PRESSURE SENSING DISC TUBING WAS BEING REMOVED FROM PUMP AND TUBING CAME APART. TUBING CAME APART BENEATH PRESSURE SENSING DISC. TUBING WAS NOT CONNECTED TO PATIENT BUT CONTAINED NMBX. 11/15/23. ITEM: 10014914 QUANTITY AFFECTED: 1 EACH. SERIAL/LOT NUMBER: NA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    732434 BD ALARIS SYRINGE MODULE SYRINGE ADMINISTRATION SET INTRAVASCULAR ADMINISTRATION SET FPA SISTEMAS MEDICOS ALARIS S.A. DE C.V. UNKNOWN 10885403233906

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown