BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SMARTSITE 20MM VENTED VIAL ACCESS DEVICE

    MDR report key: 12019203 · Received June 17, 2021

    Report

    Report Number
    9616066-2021-51335
    Event Type
    Malfunction
    Date Received
    June 17, 2021
    Date of Event
    May 20, 2021
    Report Date
    July 21, 2021
    Product Code
    FPA
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D.4. MEDICAL DEVICE LOT #: 202035. D.4. MEDICAL DEVICE EXPIRATION DATE: 9/17/2023. H.4. DEVICE MANUFACTURE DATE: 9/17/2020. H.6. INVESTIGATION: A MV0420-0006 PRODUCT WAS NOT AVAILABLE FOR INVESTIGATION; HOWEVER THE CUSTOMER CONFIRMED THAT THE COMPLAINT SAMPLE WAS FROM LOT 202035. FROM THE INFORMATION PROVIDED BY THE CUSTOMER IT APPEARS THAT THE SMARTSITE SEPARATED FROM THE VIAL ACCESS DEVICE, HOWEVER THIS COULD NOT BE CONCLUSIVELY CONFIRMED FROM THE INFORMATION PROVIDED BY THE CUSTOMER. THE DETAILS OF THIS FEEDBACK WERE SHARED WITH THE LEGAL MANUFACTURER OF THE PRODUCT, YUKON MEDICAL LLC, FOR INVESTIGATION. THE ROOT CAUSE OF THE CUSTOMER¿S EXPERIENCE COULD NOT BE DETERMINED AS THE SAMPLE WAS NOT AVAILABLE FOR INVESTIGATION. IN THIS INSTANCE, WITHOUT A SAMPLE IT IS NOT POSSIBLE TO DETERMINE WHETHER A MANUFACTURING DEFECT COULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED FAULT. A REVIEW OF THE PRODUCTION RECORDS FROM LOT 202035 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 THE SMARTSITE 20MM VENTED VIAL ACCESS DEVICE EXPERIENCED A BROKEN SPIKE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: WHEN PULLING UP MABTHERA, THE HEADING THEN THE TEXIUM VENTED VIAL SPIKE BROKE OFF . THE VIAL SUDDENLY FELL ON THE WORK SURFACE. THE AMOUNT NEEDED FOR THE PATIENT WAS ALREADY PULLED UP, SO NO PROBLEM THERE.

    Additional Manufacturer Narrative · 1

    MEDICAL DEVICE LOT #: AN INVALID LOT # OF 202035 WAS PROVIDED BY THE INITIAL REPORTER: DEVICE EXPIRATION DATE: UNKNOWN. A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED. DEVICE MANUFACTURE DATE: UNKNOWN.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE SMARTSITE 20MM VENTED VIAL ACCESS DEVICE EXPERIENCED A BROKEN SPIKE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: WHEN PULLING UP MABTHERA, THE HEADING THEN THE TEXIUM VENTED VIAL SPIKE BROKE OFF . THE VIAL SUDDENLY FELL ON THE WORK SURFACE. THE AMOUNT NEEDED FOR THE PATIENT WAS ALREADY PULLED UP, SO NO PROBLEM THERE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    917099 SMARTSITE 20MM VENTED VIAL ACCESS DEVICE INTRAVASCULAR ADMINISTRATION SET FPA 202035

    Patients

    Seq Age Sex Outcome Treatment
    1