BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD ALARIS SMARTSITE EXTENSION SET

    MDR report key: 13872784 · Received March 24, 2022

    Report

    Report Number
    9616066-2022-00308
    Event Type
    Malfunction
    Date Received
    March 24, 2022
    Date of Event
    March 9, 2022
    Report Date
    May 17, 2022
    Manufacturer
    SISTEMAS MEDICOS ALARIS, S.A. DE C.V.
    Product Code
    FPA
    UDI-DI
    37613203012288
    PMA / PMN Number
    K960280
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. DEVICE EXPIRATION DATE: UNKNOWN. A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED. DEVICE MANUFACTURE DATE: UNKNOWN.

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION: NO PRODUCT OR PHOTO WAS RETURNED BY THE CUSTOMER. IT WAS REPORTED THAT ONE SIDE OF Y-SITE DOES NOT FLUSH THROUGH. THE CUSTOMER COMPLAINT COULD NOT BE VERIFIED DUE TO THE PRODUCT NOT BEING RETURNED FOR FAILURE INVESTIGATION. A DEVICE HISTORY RECORD REVIEW COULD NOT BE PERFORMED ON MODEL 20159E BECAUSE A LOT NUMBER IS UNKNOWN. EVEN THOUGH NO SAMPLE/PHOTO WAS RECEIVED AND FAILURE COULD NOT BE CONFIRMED, CAPA#: 1998036 HAS BEEN INITIATED TO INVESTIGATE THE CUSTOMER¿S REPORTED FAILURE MODE. A TREND FOR THIS OCCLUSION ISSUE HAS BEEN IDENTIFIED FOR THIS PRODUCT LINE, AND A TEAM HAS BEEN ASSEMBLED IN ORDER TO INVESTIGATE THE ISSUE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD ALARIS SMARTSITE EXTENSION SET WAS CLOGGED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: ONE SIDE OF Y-SITE DOES NOT FLUSH THROUGH.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD ALARIS SMARTSITE EXTENSION SET WAS CLOGGED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: ONE SIDE OF Y-SITE DOES NOT FLUSH THROUGH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    863102 BD ALARIS SMARTSITE EXTENSION SET INTRAVASCULAR ADMINISTRATION SET FPA SISTEMAS MEDICOS ALARIS, S.A. DE C.V. 20159E UNKNOWN 37613203012288

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown