BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SMARTSITE 20MM VENTED VIAL ACCESS DEVICE

    MDR report key: 11388881 · Received February 26, 2021

    Report

    Report Number
    9616066-2021-50330
    Event Type
    Malfunction
    Date Received
    February 26, 2021
    Date of Event
    February 3, 2021
    Report Date
    April 1, 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
    FR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELD WAS UPDATED DUE TO CORRECTED INFORMATION: D.4. MEDICAL DEVICE LOT#: 202034. H.6. INVESTIGATION: A MV0420-0006 PRODUCT WAS NOT AVAILABLE FOR INVESTIGATION; HOWEVER THE CUSTOMER CONFIRMED THAT THE COMPLAINT SAMPLE WAS FROM LOT 202034. AS PART OF THE FEEDBACK THE CUSTOMER PROVIDED A PHOTOGRAPH OF THE AFFECTED VIAL ACCESS DEVICE (VAD), WHICH CONFIRMED THE SEPARATION OF THE SMARTSITE FROM THE VAD. 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 FROM ANALYSIS OF THE PHOTOGRAPH PROVIDED BY THE CUSTOMER. A REVIEW OF THE PRODUCTION RECORDS AS WELL AS TESTING PERFORMED ON RETAINED SAMPLES FROM LOT 202034 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 AT LEAST ONE SMARTSITE 20MM VENTED VIAL ACCESS DEVICE EXPERIENCED LUER-LOK COLLAR BREAKAGE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: BREAKS AT THE NECK JUST ABOVE THE FILTER WHEN THE SYRINGE IS SCREWED IN, APPARENTLY WITHOUT TWISTING.

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. DEVICE EXPIRATION DATE: UNKNOWN. MEDICAL DEVICE BATCH#: AN INVALID LOT # OF 202034 WAS PROVIDED BY THE INITIAL REPORTER 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. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AT LEAST ONE SMARTSITE 20MM VENTED VIAL ACCESS DEVICE EXPERIENCED LUER-LOK COLLAR BREAKAGE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: BREAKS AT THE NECK JUST ABOVE THE FILTER WHEN THE SYRINGE IS SCREWED IN, APPARENTLY WITHOUT TWISTING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    285860 SMARTSITE 20MM VENTED VIAL ACCESS DEVICE NEEDLE-FREE CONNECTOR FPA SISTEMAS MEDICOS ALARIS, S.A. DE C.V. 202034

    Patients

    Seq Age Sex Outcome Treatment
    1