BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD SMARTSITE ADD-ON BAG ACCESS DEVICE

    MDR report key: 18655299 · Received February 6, 2024

    Report

    Report Number
    9616066-2024-00195
    Event Type
    Malfunction
    Date Received
    February 6, 2024
    Date of Event
    November 14, 2023
    Report Date
    March 15, 2024
    Manufacturer
    SISTEMAS MEDICOS ALARIS S.A. DE C.V.
    Product Code
    FPA
    UDI-DI
    27613203013912
    PMA / PMN Number
    K970485
    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

    TEST SAMPLE 37 OF SKU 10013365-0006 FAILED ISO-8536 50 KPA AIR LEAK TESTING. SUBSEQUENT LEAK TESTING CONFIRMED THAT THE LEAKING ORIGINATED FROM THE SPIKE HUB AND SPIKE PORT, MORE SPECIFICALLY WHERE THE SPIKE HUB WALL MEETS THE SPIKE PORT. 1/59 SAMPLES FAILED, DOUBLED SAMPLING PLAN AND NO ADDITIONAL FAILURES NOTED. DEFECTIVE SAMPLE SENT TO TJ FOR INVESTIGATION. DEFECT RECORD AWAITING QN # OR INVESTIGATION # FOR TRACEABILITY. DEVICE HISTORY RECORD REVIEW FOR MODEL 10013365-0006 LOT NUMBER 22085920 WAS PERFORMED. THE SEARCH SHOWED THAT A TOTAL OF (B)(4) UNITS IN 1 LOT NUMBER WAS BUILT ON 31AUG2022. QN #200352045: EUMDR LEAK DEFECT RECORD - THIS WAS CREATED IN RESPONSE TO THIS COMPLAINT AND THE R&D TESTING DONE BY INTERNAL BD SOURCES.

    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

    NO ADDITIONAL INFORMATION WAS PROVIDED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD SMARTSITE ADD-ON BAG ACCESS DEVICE WAS DAMAGED THE FOLLOWING INFORMATION WAS RECEIVED BY THE INITIAL REPORTER WITH THE VERBATIM: EUMDR/ SMARTSITE BAG ACCESS DEVICE DV FAILURES - 1 SAMPLE SKU 10013365-0006 FAILED ISO-8536 50 KPA AIR LEAK TESTING. SUBSEQUENT LEAK TESTING CONFIRMED THAT THE LEAKING ORIGINATED FROM THE SPIKE HUB AND SPIKE PORT, MORE SPECIFICALLY WHERE THE SPIKE HUB WALL MEETS THE SPIKE PORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    561400 BD SMARTSITE ADD-ON BAG ACCESS DEVICE INTRAVASCULAR ADMINISTRATION SET FPA SISTEMAS MEDICOS ALARIS S.A. DE C.V. 22085920 27613203013912

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown