BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SMARTSITE 20MM VENTED VIAL ACCESS DEVICE

    MDR report key: 12137764 · Received July 8, 2021

    Report

    Report Number
    9616066-2021-51481
    Event Type
    Malfunction
    Date Received
    July 8, 2021
    Date of Event
    June 9, 2021
    Report Date
    August 6, 2021
    Product Code
    FPA
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H6: INVESTIGATION SUMMARY TWO MV0420-0006 SAMPLES WERE RECEIVED FOR INVESTIGATION, ONE IN OPENED PACKAGING FROM LOT 202040 AND THE OTHER WITHOUT PACKAGING. A VISUAL INSPECTION OF THE RETURNED SAMPLES CONFIRMED THE CUSTOMER'S EXPERIENCE, AS IN EACH INSTANCE THE SMARTSITE WAS RECEIVED SEPARATED FROM THE VIAL ACCESS DEVICE (VAD). A CLOSER INSPECTION IDENTIFIED THAT THE SAMPLE RECEIVED WITHOUT PACKAGING HAD SNAPPED AT THE TIP OF THE MALE LUER OF THE SMARTSITE, WITH THE TIP OF THE SMARTSITE STILL BONDED TO THE VAD; FOR THE SAMPLE RECEIVED WITHIN PACKAGING, THE SMARTSITE HAD SEPARATED FROM THE VAD AND NO DAMAGE WAS OBSERVED TO EITHER COMPONENT. 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 CUSTOMER'S EXPERIENCE OF SMARTSITE SEPARATION COULD NOT BE DETERMINED IN THIS INSTANCE, HOWEVER PREVIOUS INVESTIGATIONS HAVE CONFIRMED THAT SEPARATION OF THE SMARTSITE MAY OCCUR AS A RESULT OF AN INCONSISTENT OR INSUFFICIENT APPLICATION OF GLUE, COUPLED WITH THE TWISTING FORCE DURING ENGAGEMENT OR DISENGAGEMENT OF THE SMARTSITE. FOR THE PRODUCT WHERE THE SMARTSITE WAS OBSERVED DAMAGED, PREVIOUS INVESTIGATIONS HAVE CONFIRMED THAT SIMILAR DAMAGE CAN OCCUR AS A RESULT OF A LATERAL FORCE BEING APPLIED TO THE COMPONENT WHEN CONNECTED TO A SYRINGE. 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 SMARTSITE SEPARATION 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 SET IN THE PAST 12 MONTHS.

    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: BREAKAGE OF THE SPIKE BETWEEN THE GREEN PLASTIC PART AND THE VALVE. NO LEAKAGE.

    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 20MM VENTED VIAL ACCESS DEVICE EXPERIENCED A BROKEN SPIKE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: BREAKAGE OF THE SPIKE BETWEEN THE GREEN PLASTIC PART AND THE VALVE. NO LEAKAGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1030917 SMARTSITE 20MM VENTED VIAL ACCESS DEVICE INTRAVASCULAR ADMINISTRATION SET FPA 202040

    Patients

    Seq Age Sex Outcome Treatment
    1