BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SMARTSITE 20MM VENTED VIAL ACCESS DEVICE

    MDR report key: 11775030 · Received May 5, 2021

    Report

    Report Number
    9616066-2021-50889
    Event Type
    Malfunction
    Date Received
    May 5, 2021
    Date of Event
    April 6, 2021
    Report Date
    June 10, 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
    SP
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D10: DEVICE AVAILABLE FOR EVAL YES. D10: RETURNED TO MANUFACTURER ON: 2021-07-05. H6: INVESTIGATION SUMMARY: TWO MV0420-0006 DEVICES WERE RECEIVED FOR INVESTIGATION, ONE IN SEALED PACKAGING FROM LOT 202034 AND THE OTHER WITHOUT PACKAGING AND CONNECTED TO A VIAL. A VISUAL INSPECTION REVEALED THAT THE SMARTSITE OF THE SAMPLE RECEIVED WITHOUT PACKAGING WAS COMPLETELY SEPARATED FROM THE VIAL ACCESS DEVICE. FUNCTIONAL TESTING OF THE SAMPLE RECEIVED IN SEALED PACKAGING WAS PERFORMED BY CONNECTING A SYRINGE TO THE SMARTSITE OF THE VIAL ACCESS DEVICE AND OBSERVING FOR SEPARATION; NO SEPARATION WAS OBSERVED THROUGHOUT TESTING, WITH THE SMARTSITE NOTED TO BE FIRMLY CONNECTED. 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 202034 DID NOT IDENTIFY ANY IN-PROCESS TESTING FAILURES OR QUALITY DEVIATIONS WHICH MAY HAVE RESULTED IN A REPORT OF THIS NATURE. IN ORDER TO ENSURE THAT REPORTS OF THIS NATURE ARE MINIMISED IN FUTURE, YUKON MEDICAL LLC HAVE IMPLEMENTED ADDITIONAL IN-PROCESS TESTING OF THIS PRODUCT DURING FUTURE PRODUCTION. 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. H3 OTHER TEXT : SEE H10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT 15 SMARTSITE 20MM VENTED VIAL ACCESS DEVICES EXPERIENCED COMPONENT SEPARATION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: SMARTSITE BREAK IN 15 UNITS OF LOT 202034. THE FAILURE OCCURRED DURING ITS USE, IF THERE WAS A RELEASE OF MEDICATION THAT FORTUNATELY ON NO OCCASION WAS WITH HANDLING OF DANGEROUS MEDICATION. THERE WAS NO HARM TO PATIENT, IT HAS OCCURRED FOR THE PREPARATION OF MEDICATION.

    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 THAT 15 SMARTSITE 20MM VENTED VIAL ACCESS DEVICES EXPERIENCED COMPONENT SEPARATION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: SMARTSITE BREAK IN 15 UNITS OF LOT 202034. THE FAILURE OCCURRED DURING ITS USE, IF THERE WAS A RELEASE OF MEDICATION THAT FORTUNATELY ON NO OCCASION WAS WITH HANDLING OF DANGEROUS MEDICATION. THERE WAS NO HARM TO PATIENT, IT HAS OCCURRED FOR THE PREPARATION OF MEDICATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    675861 SMARTSITE 20MM VENTED VIAL ACCESS DEVICE VIAL ACCESS DEVICE FPA SISTEMAS MEDICOS ALARIS, S.A. DE C.V. 202034

    Patients

    Seq Age Sex Outcome Treatment
    1