BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD ALARIS¿ SMARTSITE¿ LOW SORBING SECONDARY SET

    MDR report key: 16152298 · Received January 12, 2023

    Report

    Report Number
    9616066-2022-02198
    Event Type
    Malfunction
    Date Received
    January 12, 2023
    Date of Event
    December 20, 2022
    Report Date
    January 28, 2023
    Manufacturer
    SISTEMAS MEDICOS ALARIS, S.A. DE C.V.
    Product Code
    FPA
    UDI-DI
    10885403221934
    PMA / PMN Number
    K790582
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A DEVICE EVALUATION IS ANTICIPATED BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 0

    H6: INVESTIGATION SUMMARY: NO PHOTO OR SAMPLE WAS RECEIVED FOR THE CUSTOMER'S COMPLAINT OF SEPARATION NO LEAK. WITHOUT FURTHER INFORMATION LIKE A PHYSICAL SAMPLE FOR INVESTIGATION, THE COMPLAINT CANNOT BE VERIFIED AND ROOT CAUSE OF THIS FAILURE REMAINS UNKNOWN. A DEVICE HISTORY RECORD REVIEW COULD NOT BE PERFORMED BECAUSE A LOT NUMBER WAS NOT PROVIDED BY THE CUSTOMER.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT AN UNSPECIFIED NUMBER OF BD ALARIS¿ SMARTSITE¿ LOW SORBING SECONDARY SETS HAD ISSUES WITH THE COMPONENTS SEPARATING DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "FYI, WHAVE SEEN A BIG UPTICK IN PRODUCT ISSUES RECENTLY. THEY ALL SEEM TO BE COMING APART SOMEWHERE IN THE SET. IT SEEMS LIKE THE GLUE IS NOT WORKING ON OUR SETS."

    Description of Event or Problem · 0

    IT WAS REPORTED THAT AN UNSPECIFIED NUMBER OF BD ALARIS¿ SMARTSITE¿ LOW SORBING SECONDARY SETS HAD ISSUES WITH THE COMPONENTS SEPARATING DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "FYI, WHAVE SEEN A BIG UPTICK IN PRODUCT ISSUES RECENTLY. THEY ALL SEEM TO BE COMING APART SOMEWHERE IN THE SET. IT SEEMS LIKE THE GLUE IS NOT WORKING ON OUR SETS."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1751309 BD ALARIS¿ SMARTSITE¿ LOW SORBING SECONDARY SET INTRAVASCULAR ADMINISTRATION SET FPA SISTEMAS MEDICOS ALARIS, S.A. DE C.V. 21069687 10885403221934

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown