BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SMARTSITE 20MM VENTED VIAL ACCESS DEVICE

    MDR report key: 12422571 · Received September 3, 2021

    Report

    Report Number
    9616066-2021-51953
    Event Type
    Malfunction
    Date Received
    September 3, 2021
    Date of Event
    August 5, 2021
    Report Date
    October 22, 2021
    Manufacturer
    SISTEMAS MEDICOS ALARIS, S.A. DE C.V.
    Product Code
    FPA
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H6: INVESTIGATION SUMMARY FIVE MV0420-0006 SAMPLES FROM LOT 202040 WERE RECEIVED FOR INVESTIGATION, ONE WAS RECEIVED WITH OPENED PACKAGING AND FOUR WERE RECEIVED IN SEALED PACKAGING. A VISUAL INSPECTION OF THE SAMPLE RECEIVED IN OPENED PACKAGING CONFIRMED THE CUSTOMER'S EXPERIENCE AS THE MALE LUER OF THE SMARTSITE HAD SNAPPED OFF FROM THE VIAL ACCESS DEVICE (VAD), WITH PART OF THE COMPONENT STILL REMAINING BONDED TO THE VAD. THE UNUSED SAMPLES WERE THEN SENT TO THE BD PRODUCT TEST LABORATORY FOR 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 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 DAMAGED SMARTSITE COULD NOT BE DETERMINED IN THIS INSTANCE, HOWEVER PREVIOUS INVESTIGATIONS HAVE CONFIRMED THAT SIMILAR DAMAGE CAN OCCUR AS A RESULT OF A LATERAL FORCE BEING APPLIED TO THE COMPONENT. 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. THE QUALITY TEAM AT THE MANUFACTURING SITE HAS BEEN INFORMED OF THIS REPORT IN ORDER TO BE AWARE OF THE REPORTED FEEDBACK DURING FUTURE PRODUCTION OF THIS PRODUCT. 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 SMARTSITE 20MM VENTED VIAL ACCESS DEVICE BROKE ON 2 OCCASIONS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: A FIRST BOTTLE ADAPTER BROKE AS SOON AS IT WAS UNPACKAGED WITHOUT HAVING BEEN HANDLED. THIS ADAPTER WAS IMMEDIATELY EXAMINED BY DR. AND KEPT BY HER FOR THE NECESSARY VERIFICATIONS. CONTINUING THE WORK, A SECOND BOTTLE ADAPTER, AFTER HAVING BEEN ATTACHED TO THE BOTTLE OF FLUOROURACIL WITHOUT APPARENT PROBLEMS, BROKE DURING THE ASPIRATION OF THE DRUG. THE GREEN PART OF THE ADAPTER REMAINED ATTACHED TO THE BOTTLE WHILE THE WHITE AND BLUE PART REMAINED ATTACHED TO THE SYRINGE RESULTING IN SPILLAGE OF ANTIBLASTIC ON THE OPERATOR'S GLOVE AND ON THE WORK SURFACE. THIS HAS LED TO DIRECT EXPOSURE TO A CYTOTOXIC DRUG FOR THE PRESENT OPERATORS, ALSO THE DRUG WHICH REMAINED IN THE BOTTLE WAS SUBSEQUENTLY UNUSABLE.

    Additional Manufacturer Narrative · 1

    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 BROKE ON 2 OCCASIONS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: A FIRST BOTTLE ADAPTER BROKE AS SOON AS IT WAS UNPACKAGED WITHOUT HAVING BEEN HANDLED. THIS ADAPTER WAS IMMEDIATELY EXAMINED BY DR. AND KEPT BY HER FOR THE NECESSARY VERIFICATIONS. CONTINUING THE WORK, A SECOND BOTTLE ADAPTER, AFTER HAVING BEEN ATTACHED TO THE BOTTLE OF FLUOROURACIL WITHOUT APPARENT PROBLEMS, BROKE DURING THE ASPIRATION OF THE DRUG. THE GREEN PART OF THE ADAPTER REMAINED ATTACHED TO THE BOTTLE WHILE THE WHITE AND BLUE PART REMAINED ATTACHED TO THE SYRINGE RESULTING IN SPILLAGE OF ANTIBLASTIC ON THE OPERATOR'S GLOVE AND ON THE WORK SURFACE. THIS HAS LED TO DIRECT EXPOSURE TO A CYTOTOXIC DRUG FOR THE PRESENT OPERATORS, ALSO THE DRUG WHICH REMAINED IN THE BOTTLE WAS SUBSEQUENTLY UNUSABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1321006 SMARTSITE 20MM VENTED VIAL ACCESS DEVICE INTRAVASCULAR ADMINISTRATION SET FPA SISTEMAS MEDICOS ALARIS, S.A. DE C.V. 202040

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown