BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SMARTSITE 20MM VENTED VIAL ACCESS DEVICE

    MDR report key: 12464839 · Received September 13, 2021

    Report

    Report Number
    9616066-2021-52020
    Event Type
    Malfunction
    Date Received
    September 13, 2021
    Date of Event
    August 16, 2021
    Report Date
    October 29, 2021
    Manufacturer
    SISTEMAS MEDICOS ALARIS, S.A. DE C.V.
    Product Code
    LHI
    PMA / PMN Number
    K151963
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D.9. DEVICE AVAILABLE FOR EVAL?: YES. D.9. RETURNED TO MANUFACTURER ON: 9/13/2021. H.6. INVESTIGATION: FOUR MV0420-0006 SAMPLES FROM LOT 202040 WERE RECEIVED IN SEALED PACKAGING FOR INVESTIGATION. 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 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 CUSTOMER¿S EXPERIENCE WAS NOT CONFIRMED IN THIS INSTANCE. TESTING OF THE RETURNED SAMPLES AND A REVIEW OF THE PRODUCTION RECORDS DID NOT IDENTIFY ANY PRODUCT DEFECTS OR QUALITY DEVIATIONS DURING ASSEMBLY. THE ALLEGED COMPLAINT SAMPLE WAS NOT AVAILABLE FOR INVESTIGATION THEREFORE IT WAS NOT POSSIBLE TO CONFIRM WHETHER A MANUFACTURING DEFECT MAY HAVE CONTRIBUTED TO THE REPORTED DAMAGE. H3 OTHER TEXT : SEE H.10.

    Description of Event or Problem · 0

    IT WAS REPORTED SMARTSITE 20MM VENTED VIAL ACCESS DEVICE WAS LOOSE, SEPARATED, AND/OR DETACHED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM ITALIAN: "WE ALSO HAD PROBLEMS LAST WEEK WITH A VIAL ADAPTER THAT BROKE DURING THE ASPIRATION OF THE PERJETA DRUG."

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED. 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 SMARTSITE 20MM VENTED VIAL ACCESS DEVICE WAS LOOSE, SEPARATED, AND/OR DETACHED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM (B)(6): "WE ALSO HAD PROBLEMS LAST WEEK WITH A VIAL ADAPTER THAT BROKE DURING THE ASPIRATION OF THE PERJETA DRUG."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1362728 SMARTSITE 20MM VENTED VIAL ACCESS DEVICE SET, IV FLUID TRANSFER LHI SISTEMAS MEDICOS ALARIS, S.A. DE C.V. 202040

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown