BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SMARTSITE 20MM VENTED VIAL ACCESS DEVICE

    MDR report key: 11588780 · Received March 30, 2021

    Report

    Report Number
    9616066-2021-50605
    Event Type
    Malfunction
    Date Received
    March 30, 2021
    Date of Event
    March 2, 2021
    Report Date
    May 26, 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
    FR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D.10. DEVICE AVAILABLE FOR EVAL?: YES D.10. RETURNED TO MANUFACTURER ON:(B)(6) 2021 THE FOLLOWING FIELD WAS UPDATED DUE TO CORRECTED INFORMATION: D.4. MEDICAL DEVICE LOT#: 202040 D.4. MEDICAL DEVICE EXPIRATION DATE: 10/15/2023 H.4. DEVICE MANUFACTURE DATE: 5/18/2021 H.6. INVESTIGATION: ONE MV0420-0006 SAMPLE FROM LOT 202040 WAS RECEIVED WITHOUT PACKAGING FOR INVESTIGATION WITH RESIDUAL FLUID IN THE DEVICE; ADDITIONALLY ONE GLASS BOTTLE OF FLUOROURACILE WAS RECEIVED WITHOUT PACKAGING. RESIDUAL FLUID WAS PRESENT IN THE BOTTLE. A VISUAL INSPECTION CONFIRMED THE CUSTOMER¿S EXPERIENCE AS THE SMARTSITE WAS RECEIVED DETACHED FROM THE VIAL ACCESS DEVICE. A CLOSER EXAMINATION OF THE NECK OF THE (B)(4) SAMPLE AND THE DETACHED SMARTSITE IDENTIFIED RESIDUAL SOLVENT AT THE AFFECTED COMPONENTS. 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 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. H3 OTHER TEXT : SEE H.10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT 2 SMARTSITE 20MM VENTED VIAL ACCESS DEVICES EXPERIENCED COMPONENT SEPARATION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: (B)(6) 2021 SPIKE INSERTION PORT DISENGAGES FROM THE SPIKE. WHEN TAKING A SAMPLE OF 5 FLUOROURACIL WITH A 60ML SYRINGE ON A SPIKE, WHEN THE SYRINGE IS WITHDRAWN: THE SPIKE INSERTION PORT SEPARATES FROM THE SPIKE AND REMAINS ON THE SYRINGE // THIS EVENT OCCURRED IDENTICALLY WHEN TAKING A SAMPLE FROM A DIFFERENT VIAL OF 5FLUOROURACIL WITH A SPIKE FROM THE SAME BATCH.

    Additional Manufacturer Narrative · 1

    MEDICAL DEVICE LOT #: AN INVALID LOT # OF 202040 WAS PROVIDED BY THE INITIAL REPORTER. DEVICE EXPIRATION DATE: UNKNOWN. A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED. DEVICE MANUFACTURE DATE: UNKNOWN.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT 2 SMARTSITE 20MM VENTED VIAL ACCESS DEVICES EXPERIENCED COMPONENT SEPARATION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: ON (B)(6) 2021 SPIKE INSERTION PORT DISENGAGES FROM THE SPIKE. WHEN TAKING A SAMPLE OF 5 FLUOROURACIL WITH A 60ML SYRINGE ON A SPIKE, WHEN THE SYRINGE IS WITHDRAWN: THE SPIKE INSERTION PORT SEPARATES FROM THE SPIKE AND REMAINS ON THE SYRINGE // THIS EVENT OCCURRED IDENTICALLY WHEN TAKING A SAMPLE FROM A DIFFERENT VIAL OF 5FLUOROURACIL WITH A SPIKE FROM THE SAME BATCH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    490567 SMARTSITE 20MM VENTED VIAL ACCESS DEVICE VIAL ACCESS DEVICE LHI SISTEMAS MEDICOS ALARIS, S.A. DE C.V. 202040

    Patients

    Seq Age Sex Outcome Treatment
    1