BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD SMARTSITE 13MM VIAL ACCESS DEVICE

    MDR report key: 21481122 · Received February 27, 2025

    Report

    Report Number
    9616066-2025-00364
    Event Type
    Malfunction
    Date Received
    February 27, 2025
    Date of Event
    January 21, 2025
    Report Date
    March 4, 2025
    Manufacturer
    SISTEMAS MEDICOS ALARIS S.A. DE C.V.
    Product Code
    FPA
    PMA / PMN Number
    K233021
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, 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.

    Additional Manufacturer Narrative · 0

    NO PRODUCT OR PHOTO WAS RETURNED BY THE CUSTOMER. THE CUSTOMER COMPLAINT OF LEAKAGE COULD NOT BE VERIFIED DUE TO THE PRODUCT NOT BEING RETURNED FOR FAILURE INVESTIGATION. A DEVICE HISTORY RECORD REVIEW FOR MATERIAL#: 2203E AND LOT#: 23105217 WAS PERFORMED. THE SEARCH SHOWED THAT A TOTAL OF (B)(4) UNITS IN 1 LOT NUMBER WAS BUILT ON 10OCT2023. THERE WERE NO QUALITY NOTIFICATIONS ISSUED FOR THE FAILURE MODE REPORTED BY THE CUSTOMER DURING THE PRODUCTION BUILD OF THIS SET. DUE TO NO SAMPLE BEING RECEIVED, AN INVESTIGATION COULD NOT BE PERFORMED, AND A ROOT CAUSE COULD NOT BE DETERMINED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD SMARTSITE 13MM VIAL ACCESS DEVICE WAS LEAKING. THE FOLLOWING INFORMATION WAS RECEIVED BY THE INITIAL REPORTER WITH THE FOLLOWING: IT WAS REPORTED BY CUSTOMER THAT VIAL ADAPTOR LEAKING DURING USE.

    Description of Event or Problem · 0

    MATERIAL#: 2203E, BATCH#: 23105217. IT WAS REPORTED BY CUSTOMER THAT VIAL ADAPTOR LEAKING DURING USE. RCC RECEIVED A COMPLAINT VIA EMAIL. COVE ID: (B)(4), DATE OF COMPANY AWARENESS: 21-JAN-2025, FG BATCH#: Y010048, BD VIAL ADAPTER BATCH: 23105217, PQC CATEGORY: VIAL ADAPTOR LEAKING DURING USE. ADDITIONAL INFORMATION REQUIRED 1. DESCRIBE ANY PATIENT HARM, INJURY, COMPLICATION OR NEGATIVE OUTCOME THAT OCCURRED AS A RESULT OF THE EVENT. DOSAGE NOT RECEIVED BY THE PATIENT. 2. ANY SAMPLE AVAILABLE FOR INVESTIGATION? IF YES, ARE YOU ABLE TO PROVIDE THE ADDRESS OF THE FACILITY FOR US TO SHIP THE RETURN LABEL? SAMPLE AVAILABLE TO SEND. 3. PLEASE SHARE THE CAPTURED PHOTO OF THE EVENT IF AVAILABLE. 4. COULD YOU PLEASE CONFIRM WHETHER THE DATE OF AWARENESS MENTIONED IN THE EMAIL IS THE DATE OF THE EVENT? IF IT IS NOT, COULD YOU KINDLY PROVIDE THE ACTUAL DATE OF THE EVENT? THE DATE OF AWARENESS IS WHAT IS USED AS THE DATE OF EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1030909 BD SMARTSITE 13MM VIAL ACCESS DEVICE INTRAVASCULAR ADMINISTRATION SET FPA SISTEMAS MEDICOS ALARIS S.A. DE C.V. 23105217

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown