BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SMARTSITE 20MM VENTED VIAL ACCESS DEVICE

    MDR report key: 12308396 · Received August 11, 2021

    Report

    Report Number
    2243072-2021-02050
    Event Type
    Malfunction
    Date Received
    August 11, 2021
    Date of Event
    July 14, 2021
    Report Date
    August 31, 2021
    Product Code
    FPA
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D10: DEVICE AVAILABLE FOR EVAL YES. D10: RETURNED TO MANUFACTURER ON: 2021-07-26. H6: INVESTIGATION SUMMARY EIGHTEEN MV0420-0006 SAMPLES WERE RECEIVED FOR INVESTIGATION IN SEALED PACKAGING FROM LOT 202040 THE REPORTED COMPLAINT SAMPLE WAS NOT RETURNED FOR INVESTIGATION. ALL EIGHTEEN SAMPLES WERE SENT TO BD PRODUCT TEST LABORATORY TO UNDERGO TENSILE TESTING IN ACCORDANCE WITH THE REQUIREMENTS OF BS: EN: ISO 8536-9: INFUSION EQUIPMENT FOR MEDICAL USE. FLUID LINES FOR USE WITH PRESSURE INFUSION EQUIPMENT. THE PRODUCT MET AND EXCEEDED THE TENSILE REQUIREMENTS OF THE STANDARD. THE DETAILS OF THIS FEEDBACK WERE SHARED WITH THE LEGAL MANUFACTURER OF THE PRODUCT, YUKON MEDICAL LLC, FOR INVESTIGATION. A DEFINITIVE ROOT CAUSE FOR OBSERVED SEPARATION REPORTED BY THE CUSTOMER 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. IN ORDER TO ENSURE THAT REPORTS OF THIS NATURE ARE MINIMISED IN FUTURE, YUKON MEDICAL LLC HAVE IMPLEMENTED ADDITIONAL IN-PROCESS TESTING OF THIS PRODUCT DURING FUTURE PRODUCTION. A REVIEW OF THE CUSTOMER FEEDBACK DATABASE INDICATES THAT THIS IS A RARE OCCURRENCE WITH A SMALL NUMBER OF SIMILAR REPORTS AGAINST THE MV0420-0006 PRODUCT IN THE PAST 12 MONTHS. H3 OTHER TEXT : SEE H10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE TOPS OF 5 SMARTSITE 20MM VENTED VIAL ACCESS DEVICES WERE INSECURELY BONDED AND DETACHED/SNAPPED OFF DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "THE TOPS WHERE YOU ATTACH THE SYRINGE DON¿T SEEM TO BE BONDED ON VERY SECURELY, WITH SEVERAL DETACHING OR SNAPPING OFF DURING USE."

    Additional Manufacturer Narrative · 1

    OEM MANUFACTURER: (B)(4). 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 TOPS OF 5 SMARTSITE 20MM VENTED VIAL ACCESS DEVICES WERE INSECURELY BONDED AND DETACHED/SNAPPED OFF DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "THE TOPS WHERE YOU ATTACH THE SYRINGE DON¿T SEEM TO BE BONDED ON VERY SECURELY, WITH SEVERAL DETACHING OR SNAPPING OFF DURING USE."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1204129 SMARTSITE 20MM VENTED VIAL ACCESS DEVICE INTRAVASCULAR ADMINISTRATION SET FPA 202040

    Patients

    Seq Age Sex Outcome Treatment
    1