BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SMARTSITE VIALSHIELD 20MM CLOSED VAD

    MDR report key: 10423111 · Received August 18, 2020

    Report

    Report Number
    9616066-2020-02463
    Event Type
    Malfunction
    Date Received
    August 18, 2020
    Date of Event
    July 28, 2020
    Report Date
    July 28, 2020
    Manufacturer
    SISTEMAS MEDICOS ALARIS, S.A. DE C.
    Product Code
    LHI
    UDI-DI
    10885403228117
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    PHARMACIST

    Narratives

    Additional Manufacturer Narrative · 0

    DUE TO NO PHOTO OR SAMPLE BEING RECEIVED, THE CUSTOMER'S COMPLAINT OF LEAKAGE COULD NOT BE VERIFIED. A DEVICE HISTORY RECORD REVIEW COULD NOT BE PERFORMED BECAUSE AN ACCURATE LOT NUMBER WAS NOT PROVIDED BY THE CUSTOMER. 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 THE SMARTSITE VIALSHIELD 20MM CLOSED VAD EXPERIENCED LEAKAGE, COMPONENT SEPARATION, AND DEVICE DAMAGE/DEFORMATION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CAREFUSION VIALSHIELD 20 MM DEVICE IS PART OF A CLOSED SYSTEM TRANSFER DEVICE TO BE USED IN THE PREPARATION OF CHEMOTHERAPY IN A PHARMACY THE CONNECTIONS ON THE DEVICE ARE SUPPOSED TO BE SEALED BY GLUE AND WERE SEPARATING ONCE A SYRINGE WAS ATTACHED THIS OCCURRED WITH 2 PRODUCTS AND A 3RD ONE BROKE AT THE CONNECTION AND LEAD TO A SMALL CHEMO SPILL STAFF WAS INSTRUCTED TO HOLD DEVICE AT THE CONNECTION TO ASSUME IT WASN'T SEALED AT MANUFACTURER'S PRODUCT WAS INTENDED

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE SMARTSITE VIALSHIELD 20MM CLOSED VAD EXPERIENCED LEAKAGE, COMPONENT SEPARATION, AND DEVICE DAMAGE/DEFORMATION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CAREFUSION VIALSHIELD 20 MM DEVICE IS PART OF A CLOSED SYSTEM TRANSFER DEVICE TO BE USED IN THE PREPARATION OF CHEMOTHERAPY IN A PHARMACY THE CONNECTIONS ON THE DEVICE ARE SUPPOSED TO BE SEALED BY GLUE AND WERE SEPARATING ONCE A SYRINGE WAS ATTACHED THIS OCCURRED WITH 2 PRODUCTS AND A 3RD ONE BROKE AT THE CONNECTION AND LEAD TO A SMALL CHEMO SPILL STAFF WAS INSTRUCTED TO HOLD DEVICE AT THE CONNECTION TO ASSUME IT WASN'T SEALED AT MANUFACTURER'S PRODUCT WAS INTENDED

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    883092 SMARTSITE VIALSHIELD 20MM CLOSED VAD VIAL ACCESS DEVICE LHI SISTEMAS MEDICOS ALARIS, S.A. DE C. MV0520 0205 10885403228117

    Patients

    Seq Age Sex Outcome Treatment
    1 Other