BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNSPECIFIED BD SMARTSITE VIALSHIELD

    MDR report key: 10422611 · Received August 18, 2020

    Report

    Report Number
    9616066-2020-02522
    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
    FPA
    PMA / PMN Number
    UNKNOWN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    PHARMACIST

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EXPIRATION DATE: UNKNOWN. DEVICE MANUFACTURE DATE: UNKNOWN. INVESTIGATION SUMMARY: THE INCIDENT COULD NOT BE VERIFIED DUE TO NO PHOTO PROVIDED. A DEVICE HISTORY RECORD REVIEW COULD NOT BE PERFORMED DUE TO NO MODEL#. DUE TO NO SAMPLE BEING RECEIVED, AN INVESTIGATION COULD NOT BE PERFORMED AND A ROOT CAUSE COULD NOT BE DETERMINED. THIS INCIDENT HAS BEEN ADDED TO OUR DATABASE OF REPORTED INCIDENTS. OUR BUSINESS TEAM REGULARLY REVIEWS THE COLLECTED DATA FOR IDENTIFICATION OF EMERGING TRENDS. INVESTIGATION CONCLUSION: NO PRODUCT WILL BE RETURNED PER CUSTOMER. NO INVESTIGATION WAS PERFORMED. ROOT CAUSE DESCRIPTION: 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 · 1

    IT WAS REPORTED THAT 2 UNSPECIFIED BD SMARTSITE VIALSHIELDS EXPERIENCED COMPONENT SEPARATION AND LEAKAGE. 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
    883076 UNSPECIFIED BD SMARTSITE VIALSHIELD VIAL ACCESS DEVICE FPA SISTEMAS MEDICOS ALARIS, S.A. DE C. UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Other