BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SMARTSITE 20MM VENTED VIAL ACCESS DEVICE

    MDR report key: 12565469 · Received October 1, 2021

    Report

    Report Number
    9616066-2021-52149
    Event Type
    Malfunction
    Date Received
    October 1, 2021
    Date of Event
    September 3, 2021
    Report Date
    November 15, 2021
    Manufacturer
    SISTEMAS MEDICOS ALARIS, S.A. DE C.V.
    Product Code
    LHI
    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

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D.9. DEVICE AVAILABLE FOR EVAL?: YES. D.9. RETURNED TO MANUFACTURER ON: 10/7/2021. H.6. INVESTIGATION: ONE MV0420-0006 SAMPLE FROM LOT 212002 WAS RECEIVED WITHOUT PACKAGING FOR INVESTIGATION. THERE WAS NO RESIDUAL FLUID IN THE DEVICE. THE CUSTOMER ALSO REPORTED THAT THIS PROBLEM HAD BEEN OBSERVED IN ANOTHER MV0420-0006 SAMPLE WHICH WAS DISPOSED OF. A VISUAL INSPECTION IDENTIFIED THAT THE AIR-VENT OF THE VIAL ACCESS DEVICE (VAD) WAS DETACHED FROM THE MV0420-0006 SAMPLE CONFIRMING THE CUSTOMER¿S EXPERIENCE. THE SEPARATED AREA OF THE AIR VENT HAD JAGGED EDGES INDICATING THAT THE DETACHMENT OCCURRED DUE TO BREAKAGE OF THE 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 OBSERVED DAMAGE COULD NOT BE DETERMINED; HOWEVER PREVIOUS INVESTIGATIONS INTO REPORTS OF THIS NATURE HAVE IDENTIFIED THAT SIMILAR DAMAGE CAN OCCUR AS A RESULT OF THE APPLICATION OF AN EXCESSIVE PERPENDICULAR FORCE, THE ROOT CAUSE OF WHICH COULD NOT BE DETERMINED IN THIS INSTANCE. A REVIEW OF THE PRODUCTION RECORDS FROM LOT 212002 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 WHEN USING THE SMARTSITE 20MM VENTED VIAL ACCESS DEVICE, THE DEVICE EXPERIENCED COMPONENT SEPARATION CAUSING LEAKAGE. DETACHMENT OF THE SEGMENT WHERE THE AIR COMPENSATION FILTER IS LOCATED LAST WEEK BY OPENING A PACKAGE OF THE SPIKE CALLED "20MM SMART SIRE VENTED VIAL ACCESS DEVICE" REF (B)(4), LOT 212002, EXPIRY 21/01/2024, THE ROUND FILTER HAS DETACHED FROM THE BODY OF THE DEVICE EVEN BEFORE USING IT . TODAY A REMNANT OF THE DRUG HYCAMTIN (TOPOTECAN) FROM THE PREVIOUS DAY WAS USED; DURING THE WORK SESSION THE SPIKE MOUNTED ON THE BOTTLE HAS LOST THE ROUND FILTER. THE SPIKE IN QUESTION IS THE SAME ONE MENTIONED ABOVE WITH THE SAME BATCH. EVENT HAPPENED TWICE IN THE WEEK FROM (B)(6) 2021 TO (B)(6) 2021 ONCE WHEN THE PACKAGING IS OPENED ANOTHER TIME AFTER USE (IN FACT ONLY ONE DEVICE IS WITHDRAWN BECAUSE THE OTHER IS CONTAMINATED) THE BATCH AND THE EXPIRY DATE OF THE DEVICES ARE THE SAME.

    Additional Manufacturer Narrative · 1

    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 WHEN USING THE SMARTSITE 20MM VENTED VIAL ACCESS DEVICE, THE DEVICE EXPERIENCED COMPONENT SEPARATION CAUSING LEAKAGE. DETACHMENT OF THE SEGMENT WHERE THE AIR COMPENSATION FILTER IS LOCATED LAST WEEK BY OPENING A PACKAGE OF THE SPIKE CALLED "20MM SMART SIRE VENTED VIAL ACCESS DEVICE" REF MV0420-0006 , LOT 212002, EXPIRY 21/01/2024, THE ROUND FILTER HAS DETACHED FROM THE BODY OF THE DEVICE EVEN BEFORE USING IT - TODAY A REMNANT OF THE DRUG HYCAMTIN (TOPOTECAN) FROM THE PREVIOUS DAY WAS USED; DURING THE WORK SESSION THE SPIKE MOUNTED ON THE BOTTLE HAS LOST THE ROUND FILTER. THE SPIKE IN QUESTION IS THE SAME ONE MENTIONED ABOVE WITH THE SAME BATCH. EVENT HAPPENED TWICE IN THE WEEK FROM (B)(6) 2021 ONCE WHEN THE PACKAGING IS OPENED ANOTHER TIME AFTER USE (IN FACT ONLY ONE DEVICE IS WITHDRAWN BECAUSE THE OTHER IS CONTAMINATED) THE BATCH AND THE EXPIRY DATE OF THE DEVICES ARE THE SAME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1463555 SMARTSITE 20MM VENTED VIAL ACCESS DEVICE IV SET, FLUID TRANSFER LHI SISTEMAS MEDICOS ALARIS, S.A. DE C.V. 212002

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown