BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SMARTSITE 20MM VENTED VIAL ACCESS DEVICE

    MDR report key: 11882960 · Received May 26, 2021

    Report

    Report Number
    9616066-2021-51156
    Event Type
    Malfunction
    Date Received
    May 26, 2021
    Date of Event
    April 27, 2021
    Report Date
    June 22, 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
    IT
    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: 2021-07-01. H6: INVESTIGATION SUMMARY : TEN MV0420-0006 SAMPLES WERE RECEIVED FOR INVESTIGATION, EACH SAMPLE WAS RECEIVED IN SEALED PACKAGING FROM LOT 202040. FUNCTIONAL TESTING INVOLVED CONNECTING A 50ML BD PLASTIPAK SYRINGE TO THE SMARTSITE OF EACH OF THE VIAL ACCESS DEVICES, AND MANIPULATING THE TWO PRODUCTS WHILE CONNECTED; IN EACH INSTANCE THE COMPONENTS WERE OBSERVED TO BE SECURELY CONNECTED AND NO SEPARATION WAS OBSERVED. THE DETAILS OF THIS FEEDBACK WERE FORWARDED TO THE LEGAL MANUFACTURER OF THE PRODUCT, YUKON MEDICAL LLC, FOR INVESTIGATION. A DEFINITIVE ROOT CAUSE FOR THE REPORTED SEPARATION COULD NOT BE DETERMINED IN THIS INSTANCE AS THE SAMPLE WAS NOT AVAILABLE FOR INVESTIGATION, FURTHERMORE NO SEPARATION WAS IDENTIFIED DURING TESTING OF THE RETURNED UNUSED SAMPLES. 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. ALTHOUGH IT WAS NOT POSSIBLE TO DETERMINE A DEFINITIVE ROOT CAUSE FOR THE CUSTOMER'S EXPERIENCE, AS A RESULT OF A SMALL NUMBER OF SIMILAR REPORTS 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 SMARTSITE 20MM VENTED VIAL ACCESS DEVICE CAME APART. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: BREAKAGE OF A 20 MM BOTTLE ADAPTER WHICH RESULTED IN THE ELIMINATION OF A BOTTLE OF ONTRUZANT 150MG. SALES REP: WHILE USING THE COD. THE NFC SMARTSITE SYSTEM HAS DETACHED FROM THE DEVICE. IT WAS USED WITH TEXIUM SYRINGE.

    Additional Manufacturer Narrative · 1

    A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED, BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT SMARTSITE 20MM VENTED VIAL ACCESS DEVICE CAME APART. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: BREAKAGE OF A 20 MM BOTTLE ADAPTER WHICH RESULTED IN THE ELIMINATION OF A BOTTLE OF ONTRUZANT 150MG. SALES REP: WHILE USING THE COD. THE NFC SMARTSITE SYSTEM HAS DETACHED FROM THE DEVICE. IT WAS USED WITH TEXIUM SYRINGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    779616 SMARTSITE 20MM VENTED VIAL ACCESS DEVICE INTRAVASCULAR ADMINISTRATION SET FPA SISTEMAS MEDICOS ALARIS, S.A. DE C.V. 202040

    Patients

    Seq Age Sex Outcome Treatment
    1