BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SMARTSITE 20MM VENTED VIAL ACCESS DEVICE

    MDR report key: 12194133 · Received July 19, 2021

    Report

    Report Number
    9616066-2021-51556
    Event Type
    Malfunction
    Date Received
    July 19, 2021
    Date of Event
    June 18, 2021
    Report Date
    August 17, 2021
    Product Code
    FPA
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D.10. DEVICE AVAILABLE FOR EVAL?: YES D.10. RETURNED TO MANUFACTURER ON: 8/16/2021 H.6. INVESTIGATION: ONE MV0420-0006 SAMPLE WAS RECEIVED WITHOUT PACKAGING FOR INVESTIGATION OF PR 3103112 AND 3115483, THE CUSTOMER INDICATES THAT THE LOT NUMBER OF THE AFFECTED PRODUCT WAS 202040. THE SAMPLE WAS RECEIVED CONNECTED TO A CELLTECH MF-F100ML VIAL, WITH A VOLUME OF CHEMOTHERAPY FLUID INSIDE THE VIAL. A VISUAL INSPECTION CONFIRMED THE CUSTOMER'S EXPERIENCE, AS THE SMARTSITE COMPONENT OF THE DEVICE HAD COMPLETELY SEPARATED FROM THE VIAL ACCESS DEVICE. THE DETAILS OF THIS FEEDBACK WERE SHARED WITH THE LEGAL MANUFACTURER OF THE PRODUCT, YUKON MEDICAL LLC, FOR INVESTIGATION. A DEFINITIVE ROOT CAUSE FOR THE OBSERVED SEPARATION COULD NOT BE DETERMINED, HOWEVER IT IS POSSIBLE THAT IT OCCURRED AS A RESULT OF AN INCONSISTENT OR INSUFFICIENT APPLICATION OF GLUE, COUPLED WITH THE TWISTING FORCE DURING ENGAGEMENT OR DISENGAGEMENT OF THE SMARTSITE. A REVIEW OF THE PRODUCTION RECORDS FROM LOT 202040 DID NOT IDENTIFY ANY IN-PROCESS TESTING FAILURES OR QUALITY DEVIATIONS WHICH MAY HAVE RESULTED IN A REPORT OF THIS NATURE. H3 OTHER TEXT : SEE H.10

    Description of Event or Problem · 0

    IT WAS REPORTED THAT SMARTSITE 20MM VENTED VIAL ACCESS DEVICE DISCONNECTED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: USE OF THE DEVICE WITH SMARTSITE AND SECURE DOCKING SYSTEM FOR MULTIPLE ACCESS TO 20 MM DIAMETER VIALS FOR PREPARATION/DILUTION OF ANTIBLASTIC THERAPY. DURING THE ASPIRATION PHASE OF THE CONCENTRATE FROM THE EXTRACTION VIAL, THE CONNECTOR, THAT SHOULD HAVE BEEN THERMO-WELDED, DROPPED CAUSING THE DISCONNECTION OF THE CLOSED SYSTEM FROM THE BREAKING POINT.

    Additional Manufacturer Narrative · 1

    INITIAL REPORTER FACILITY: (B)(6). A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED, BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT SMARTSITE 20MM VENTED VIAL ACCESS DEVICE DISCONNECTED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: USE OF THE DEVICE WITH SMARTSITE AND SECURE DOCKING SYSTEM FOR MULTIPLE ACCESS TO 20 MM DIAMETER VIALS FOR PREPARATION/DILUTION OF ANTIBLASTIC THERAPY. DURING THE ASPIRATION PHASE OF THE CONCENTRATE FROM THE EXTRACTION VIAL, THE CONNECTOR, THAT SHOULD HAVE BEEN THERMO-WELDED, DROPPED CAUSING THE DISCONNECTION OF THE CLOSED SYSTEM FROM THE BREAKING POINT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1085975 SMARTSITE 20MM VENTED VIAL ACCESS DEVICE INTRAVASCULAR ADMINISTRATION SET FPA 202040

    Patients

    Seq Age Sex Outcome Treatment
    1